MAUDE Adverse Event Report: COOK INC REDO SINGLE LUMEN TPN CATHETER SET

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

Common device name, g5- pma/510(k) #: these fields are not applicable to the complaint device as it is not sold in the u.S.; however, this device is considered clinically similar to cook upic and cvc devices, thus prompting this report.Customer (person): email: (b)(6).Reporter occupation: unknown.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that the catheter connector of a redo single lumen tpn catheter set broke, leaving "traces of blood" on the child patient's "bodysuit".As a result, parenteral nutrition was discontinued and a peripheral venous route was established.The device was later removed and replaced.On (b)(6) 2019, the child was transferred from the user facility to a different facility's gastroenterology department due to a sasm (sensitive aureus staphylococcus) on an existing catheter, which is reported under manufacturer report #: 1820334-2020-01307.On (b)(6) 2019, the complaint device was implanted in place of the infectious device.The patient was transferred back to the user facility on (b)(6) 2019.On (b)(6) 2020, a break was noticed in the catheter connector after the child patient was found with "traces of blood" on his "bodysuit".Parenteral nutrition, which was previously being administered through the device, was discontinued.The catheter was clamped and "alcohol-based compresses on the tip" were used.A peripheral catheter was placed and the patient was monitored.The patient was transferred again and a new device was placed.On 1(b)(6) 2020, the patient was transferred one more time; it was later confirmed on (b)(6) 2020 that the child was fitted at home with a new catheter.No other adverse effects to the patient have been reported.Additional information regarding the patient, device, and event has been requested but is currently unavailable.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information regarding the patient, device, and event was received on 21jul2020.Parenteral nutrition was the indication for placement for the device.The device was placed in the patient's "dorsal on the left" to be used for both nutrition and antibiotic administration.The device failed between the wings at the start of the night around 11 p.M.The catheter was connected to a "compatible connexion : extension + two way valve".Saline was used to maintain the catheter and a 10ml minimum syringe was used for flushing.The device was secured to the patient using an "usual band-aid".The patient was described to be "very active".

Event Description

In additional information received on 28aug2020, it was clarified that no new catheter was placed on (b)(6) 2020.The child was sent back home.A new tpn catheter (manufacturer unknown) was placed on (b)(6) 2020 at (b)(6) hospital and the child was later transferred back to chu limoges (user facility).Cook has contacted the user facility in attempt to gain clarification on the sequence of events for this complaint.The initial reporter no longer works at the user facility, however, the user facility has stated that further attempts to gain clarification will continue.Should this information be received, a follow-up mdr will be submitted within 30 days of receiving the information.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information, correction: b5 this report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

In additional information received on 10aug2020, it was reported that the patient started to experience a fever with no associated signs on (b)(6) 2020 that prompted testing for an infection.On (b)(6) 2020, the patient was treated with vancomycine 40mg/kg/day and gentamycine 5 mg/kg/day.Orbenine 750 mg/6h for 14 days was then started on (b)(6) 2020.The last report of a negative hemoculture followed after the alcohol based compresses applied to the tip.According to the nurse who took care of the child patient, no defects were noted on the catheter during the removal; hourly monitoring was performed throughout the night to check that there is no flow, "nothing to report.".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H6- additional method code: analysis of production records (3331) investigation - evaluation chu limoges user facility, located in france, reported an incident to cook on 09jul2020 involving a redo single lumen tpn catheter set (rpn: c-tpns-4.0-65-redo) from lot #9514413.It was reported that the device's catheter connector broke.This patient experienced a series of three events of which are reported under mdr ref.#1820334-2020-01309 and mdr ref.#1820334-2020-01307.This report will cover the catheter infection treated with antibiotics as well as broken catheter connector (same device) occurring on (b)(6) 2020.The male pediatric patient was diagnosed with trichohepatoenteric syndrome involving the following: liver damage, fine blonde hair, atopic dermatitis (latte stains), rhinoplasty to repair cleft lip and palate, igg/iga immune deficiency, and intrauterine grown retardation (rciu), less than 3rd percentile.The patient¿s activity level was reported to be ¿very active¿.On (b)(6) 2020 while an inpatient at (b)(6) hospital, the patient presented with a fever without any associated signs of infection.The suspected line infection was treated with medications beginning on (b)(6) 2020.Medications administered included: vancomycin 40mg/kg/day & gentamicin 5 mg/kg/day (treatment began on (b)(6) 2020) orbenine (cloxacillin) 750 mg/6h for 14 days.(treatment began on (b)(6) 2020).The patient¿s last negative hemoculture report was (b)(6) 2020.After the treatment for infection on the redo single lumen tpn catheter set (rpn: c-tpns-4.0-65-redo, lot number 9514413), a device failure was discovered.On (b)(6) 2020, a chu limoges nurse discovered the patient had traces of blood on his t-shirt.At the time of the discovery the patient was receiving tpn.The redo single lumen tpn catheter line was clamped by the nurse and alcoholic compresses were placed on the end of the line; tpn infusion was discontinued.The catheter failure was reported to be between the wings of the catheter.A peripheral intravenous catheter was placed in the patient and monitoring was completed hourly throughout the night to ensure that there was no leaking of the device.The device was removed on (b)(6) 2020 at chu limoges hospital.According to the nurse who took care of child, no defects were noted on the catheter during the removal.On (b)(6) 2020, the patient had a new cook tpn catheter placed at necker hospital.The patient was then transferred back to chu limoges.A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One redo single lumen tpn catheter set fitting was returned to cook for evaluation.The catheter component was not returned.A visual inspection of the returned device portion (winged hub with a needleless connector attached) found no cracks on the fitting.Cook has concluded that this device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot (9514413) and the related catheter component lot revealed no recorded non-conformances related to the failure mode.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and there are no other lot related complaints that have been received from the field from other customers, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The set is supplied with an ifu which includes the following in relation to the failure mode: "warnings -if lumen flow is impeded, do not fie injection or withdrawal of fluids.Notify the attending physician immediately precautions -placemen into the subclavian vein may result in compression of the catheter by the clavicle and first rib.Excessive compression may result in catheter damage, including rupture or catheter embolus.-silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10ml syringe or larger will reduce the risk of catheter rupture.Suggested catheter maintenance.If catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparanized saline solution.Catheter heperanization should be determined by intuitional protocol and clinical judgement.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Before use catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin or saline lock.Strict septic technique must be adhered to while using and maintaining catheter how supplied supplied sterilized by ethylene oxide gas in peel-open packages.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile" based on the information provided, inspection of the returned product, and the results of the investigation, a definitive root cause was unable to be established.Based on the information provided, cook has been unable to rule out inadvertent tension placed on the device due to patient activity, inadvertent tension placed on the line due to caregiver movement of the patient during activities of daily living or in transfer, or manufacturing as a cause of this event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: h6 - method code, results code.Investigation - evaluation: in regards to the infection that developed in the line, it was concluded that the most probable causes of this event are related to the patient's pre-existing conditions and possibly the lack of strict aseptic technique while using and maintaining the catheter.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

In an email received on 17sep2020, the timeline for this event and the related events associated with patient identifier (b)(6) was confirmed.There was a suspected line infection for this device, placed on (b)(6) 2019, which had a negative hemoculture report on (b)(6) 2020.The device was removed on (b)(6) 2020.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: REDO SINGLE LUMEN TPN CATHETER SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10284116
• MDR Text Key: 202545674
• Report Number: 1820334-2020-01309
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002079038
• UDI-Public: (01)00827002079038(17)220513(10)9514413
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2022
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-4.0-65-REDO
• Device Lot Number: 9514413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 07/21/2020; 08/10/2020; 08/28/2020; 09/17/2020; 11/02/2020; 11/02/2020
• Supplement Dates FDA Received: 07/27/2020; 08/27/2020; 09/11/2020; 10/06/2020; 11/03/2020; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention