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

Model Number G07935

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

Date of birth: born in 2019.Common device name: not available as this device is not sold in the us, but it is considered to be clinically similar to a device that is, thus prompting this report.Occupation: unknown.Pma/510(k): not available as this device is not sold in the us, but it is considered to be clinically similar to a device that is, thus prompting this report.(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 a redo double lumen tpn catheter burst during injection.The catheter was placed into the right thorax of the pediatric patient on (b)(6) 2020.On (b)(6) 2020, the catheter burst during an unknown injection given in the pediatrics department.The patient was put under anesthesia in order to have the device removed and replaced.This led to an interruption in therapy for the patient.No additional adverse effects to the patient have been reported.

Event Description

In the device failure analysis signed on (b)(6) 2021, it was found that the red hub plunger would not release fluid.Encrustation was noted on the device.While fluid was able to exit the distal tip of the blue hub, a lot of resistance was noted in doing so.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 related to the event was provided on 21dec2020.The placement site of the catheter was reported to be "left site".After placement of the device, an x-ray was completed.A 1ml syringe was used when injecting an unknown fluid; it was reported that some bigger (10ml syringes) do not work.When not in use, the catheter was locked with "5ml heparin 100e/ml = 500e".Flushing of the device was not completed before injection of the medication.The catheter was attached to the patient with "foil dressing and some safety paving".Neither anti-tamper devices or needleless connectors were used with the device.The patient was reported to be a baby in "good conditions".Their activity level was described as "moving normally".

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.

Manufacturer Narrative

Investigation - evaluation: it was reported by insel gruppe ag in switzerland that a redo double lumen tpn catheter set (rpn: c-tpns-5.0d-65-12-redo, lot number 8439317) burst while it was being injected.The female patient was reported to have been born in 2019 and was being treated in the pediatrics unit.It was reported that the patient was in ¿good conditions¿ and was moving normally for a baby.The device was placed in the right side of the thorax on (b)(6) 2020.Imaging confirmation (x-ray) of the device placement was completed on (b)(6) 2020.The catheter was secured to the patient using ¿foil dressing and some safety paving¿, assumed to be a dressing with tape securement.No needleless connectors or anti-tamper devices were being used with the catheter.When not in use, the catheter was locked with 5ml heparin 100e/ml = 500e heparin.On 23nov2020, a 1 milliliter (ml) syringe was used to inject an unknown fluid into the device.It was reported that despite being ¿open¿ before using, the catheter burst.The customer reported that ¿a 10 ml syringe does not work¿ and the catheter was not flushed before the injection of fluid.The device was removed and replaced surgically under anesthesia on (b)(6) 2020.A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control, as well as a visual inspection and functional test of the returned device, was conducted during the investigation.One used redo double lumen tpn catheter set was returned to cook for evaluation.Upon visual inspection, encrustation was noted on the device.The catheter was returned with its cuff still attached, which appeared to have tissue/dried bodily fluid on it.A blue suture was noted at three locations on the catheter- on the tubing between the suture beads and on the catheter tubing at two locations, adjacent to the suture beading.A functional test noted that the red hub plunger would not release fluid.Fluid was able to come out of the distal tip of the blue hub with resistance.No splits in the catheter were noted.It was confirmed that the red hub lumen was fully occluded, while the blue hub lumen was partially occluded.Cook has concluded that the 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 (8439317) and the related catheter component lot revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device lot.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, it was concluded that there is no evidence that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The redo double lumen tpn catheter set was supplied with ifu c_t_tpn_rev7, which includes the following in relation to the reported failure mode: ¿warnings: if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify the attending physician immediately.Precautions: volumes indicated are for untrimmed catheters.If catheter is trimmed, volumes should be adjusted accordingly.The catheter size should be as small as the use will allow, as larger diameter catheters have more tendency to promote clots.Silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10 ml 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 heparinized saline solution.Normal saline lock is permissible if utilizing the clc2000 injection cap.Catheter heparinization should be determined by institutional protocol and clinical judgement.Heparin concentrations of 10 units/ml to 100 units/ml have been reported adequate to maintain lumen patency.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 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 again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin or saline lock.Strict aseptic technique must be adhered to while using and maintaining catheter.¿ based on the information provided, inspection of the returned device, and the results of the investigation, a potential root cause for this event has been traced to the user's failure to follow instructions.The customer reported that a 1 ml syringe was used when injecting fluid, as a "10 ml syringe does not work".The reported catheter burst was likely a result of using a syringe size smaller than recommended.However, the reported burst could have also been a result of occlusion due to improper catheter maintenance.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.

• Brand Name: REDO DOUBLE LUMEN TPN CATHETER SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10941399
• MDR Text Key: 219383374
• Report Number: 1820334-2020-02229
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002079359
• UDI-Public: (01)00827002079359(17)210104(10)8439317
• 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
• Report Date: 04/14/2021

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: 01/04/2021
• Device Model Number: G07935
• Device Catalogue Number: C-TPNS-5.0D-65-12-REDO
• Device Lot Number: 8439317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 12/21/2020; 02/15/2021; 04/12/2021
• Supplement Dates FDA Received: 01/04/2021; 02/15/2021; 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention