MAUDE Adverse Event Report: COOK INC REDO SINGLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Separation Problem (4043)

Patient Problems Air Embolism (1697); Bacterial Infection (1735); Nausea (1970); Pain (1994); No Code Available (3191)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 hub of a redo single lumen tpn catheter set was found broken off completely after placement.Consequently, the patient developed an air embolism.The device was replaced.Additional information regarding the device, patient, and event has been requested but is currently unavailable.

Event Description

Additional information was received on 27mar2020.Overall patient outcome is that he had multiple investigations, a prolonged admission, a line infection, and a line replacement.A copy of the patient notes are below.On (b)(6) 2019 , the patient was brought by ambulance to (b)(6) hospital emergency department.The patient is reported as stating that while infusing his parenteral nutrition overnight it was intermittently alarming.He disconnected the infusion and tried to flush his line, however, he was unable to flush it.He attempted to aspirate it but was unable to aspirate any blood, he repeated his attempts to aspirate and then got a small amount of blood back.He then believes he accidently injected approximately 5 mls of air.Immediately, he experienced chest pain, facial numbness and difficulty breathing.An ambulance was called and was brought to naas.Raised jugular venous pressure was noted on arrival to naas.On (b)(6) 2019, the doctor stated that the patient;s symptoms had resolved and he had no arm/neck/facial swelling, no pain in the chest/shoulder/interscapular region, and no limb weakness, but he did have a headache.He had a chest x-ray and ecg which revealed no abnormalities and found the tip of the line was positioned correctly in the right atrium.The patient was transferred to (b)(6) hospital for admission and for further review.On arrival, he felt unwell and complained of left sided chest pain radiating to his throat.He was coughing persistently and felt nauseous and made several attempts to vomit but was unable to.Another ecg noted changes and that the patient was tachycardic.He was "brought straight to resuscitation".On (b)(6) 2019, the patient developed a fever of 38 degrees celsius, and complained of an ongoing worsening headache, building pressure in head, and photophobia, the diagnostic test results are below: - ecg: right ventricular strain pattern - echo: normal study with no evidence of increased rt heart pressures - ctpa: no embolus identified.No consolidation.No pleural effusion.No cause for patient's hypoxia identified.- ct brain: no acute intracranial abnormality - ir linogram completed following admission: no evidence of fracture and line in good position.The port aspirated and flushed satisfactorily.- lumbar puncture ¿ negative for rbc¿s, wbc¿s and bacteria - chest xray showed lungs clear.- mri brain ¿ nil acute (delay in getting this done) - msu/ stool culture - negative.The patient also acquired a line infection while in the hospital -staph epidermidis and staph haemolyticus.He was treated with 7/7 course iv teicoplanin.The line was removed on (b)(6) 2019 and another was inserted by ir on (b)(6) 2019.On (b)(6) 2019 the patient was discharged home.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction: b1, h6 - device code.Additional information: b2, b3, b5, d6, d7, h6 - patient code h6 - patient code: fever (1858).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: 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.

Event Description

In additional information received on 13mar2020, it was reported that the patient was admitted on (b)(6) 2019 for an air embolus after he accidentally injected air into his line.So although the hub did break off, the air embolism was with a different line.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation evaluation.It was reported a patient experienced a line infection for a catheter from a redo single lumen tpn catheter set (part number c-tpns-6.5-90-redo, lot number unknown).The patient acquired line infection while in hospital which was reported to be staph epidermidis and staph haemolyticus.The patient was treated with 7/7 course of iv teicoplanin.The catheter was removed on (b)(6) 2019 and a catheter placed by (b)(6) on (b)(6) 2019.The patient was originally admitted to the hospital after inadvertently injecting air into their catheter, resulting in a suspected air embolism on (b)(6) 2019.The patient reported that while infusing his parenteral nutrition overnight, the infusion pump was intermittently alarming.The patient disconnected the infusion line and tried to flush the line unsuccessfully.He attempted to aspirate blood but was unable; after repeated attempts a small amount of blood returned.The patient believes he accidently injected approximately 5 ml of air during the repeated blood aspiration attempts.On (b)(6) 2019 after the patient had been admitted the patient developed a fever (38 deg c), complaining of an ongoing and worsening headache, building pressure in head and photophobia.As part of the diagnostics when the developed a fever interventional radiology checked the position of the catheter and the position was confirmed to be good and there was no evidence of fracture.The catheter aspirated and flushed satisfactorily.A review of documentation including the instructions for use (ifu), manufacturing instructions, quality control and specifications of the device was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that current processes and quality inspections checks are in place to ensure the functionality and device integrity prior to shipment.It could be concluded that the complaint device was inspected by quality control per current specification.A review of the device history record (dhr) could not be conducted, as lot information was not provided.An additional complaint was opened from this event, for the hub that was partially broken away (mfg.Report reference #: 1820334-2020-00501).The instructions for use (ifu), provides the following information related to the reported failure mode: the intended use of cook tpn catheters are for ¿the administration of parenteral nutrition, chemotherapy, other therapeutic drugs and blood.¿ in this complaint it was reported to be used for parenteral nutrition of the patient.Per ifu, there are no known contraindications for use.¿extreme caution must be used in placement and monitoring.¿ no information was provided on the device¿s initial placement or how the device was being monitored prior to patient presentation to hospital.¿if blood is not freely aspirated, catheter tip position should be immediately reevaluated by the physician.¿ the patient reported failure in obtaining a blood return with ease.The patient, per ifu, should have made immediate contact to his physician to confirm placement and function.However, the patient admitted to attempting aspiration multiple times.Flushing and aspirating multiple times without using proper techniques could contribute to increased risk of infection.¿if the catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Before using catheter lumen already locked with heparin, lumen should be flushed twice the indicated lumen volume using normal saline.Lumen should be flushed 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.¿ no information was provided on the maintenance protocol utilized for the care of this catheter.Inappropriate maintenance of the catheter could contribute to an infectious process.¿strict aseptic technique must be adhered to while using and maintaining catheter.¿ it is unknown what patient education was provided regarding use of aseptic technique, and it if were always adhered to when using and maintaining the catheter.Additionally, it is unknown of the procedures used by hospital staff when accessing the catheter and maintaining it during the patient¿s hospitalization.Based on the information provided, no returned product and the results of our investigation, it was concluded that unintended use error, whilst the patient was attempting to flush their catheter, contributed to air being injected into the line.Regarding the bacterial infection, a definitive cause was not established.A review of the production processes found controls are in place for sterilization and packaging.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.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 patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: REDO SINGLE LUMEN TPN CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9770317
• MDR Text Key: 192753543
• Report Number: 1820334-2020-00500
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K950118
• 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
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-6.5-90-REDO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention