MAUDE Adverse Event Report: COOK INC COOK TPN SINGLE LUMEN CATHETER REPAIR SET; DQY CATHETER, PERCUTANEOUS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 08/02/2022

Event Type  Injury  

Event Description

It was reported that the patient had a translumbar tunneled central venous catheter (cvc) that required repair on (b)(6) 2020.A repair was completed with a cook tpn single lumen catheter repair set (rpn: c-rhcs-6.5, lot number 9836148).Two years later, the same cvc required another repair at the same location.During the repair, it was noted that the metal rod of the previous repair kit had migrated towards the insertion point of the catheter and was located at the area where the cvc securement device had been placed.The metal rod was then pushed back towards the catheter hub before the lumen was cut for repair.The lumen was repaired with another cook tpn single lumen catheter repair set, (rpn: c-rhcs-6.5, lot number 9836148).The patient did not experience any additional adverse effects due to this occurrence.Information regarding event details has been requested, but is currently unavailable.

Manufacturer Narrative

Event date: two dates of event were reported: on (b)(6) 2022.Initial reporter occupation: unknown.Pma/510k: preamendment.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

No additional information regarding the patient and/or event 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.Investigation ¿ evaluation uz leuven (belgium) contacted cook concerning a c-rhcs-6.5 (cook tpn single lumen catheter repair set) from lot# 9836148.The customer stated that during a tunneled catheter repair, it was discovered that the metal rod had migrated in the catheter.The rod was found at the level of the catheter fixation device but was able to be pushed back towards the hub of the catheter.The catheter was repaired.There were no adverse effects to the patient.The date of this event was on (b)(6) 2022, and cook became aware of this event on (b)(6) 2022.Reviews of the complaint history, device history record (dhr), quality control, and instructions for use (ifu), as well as a visual inspection of the returned device were conducted during the investigation.One 6.5fr catheter repair extension with tubing was returned to cook for evaluation.The device measured 28.5 cm from hub to distal end.The distal end of the catheter had two catheter repair cylinder covers located at 23.9cm at the distal end.The hub of the catheter extension had a transparent needleless connector and orange cap attached.A small silver cannula was returned as well.There was no evidence of adhesive on the metal cannula.The metal cannula could move freely within the lumen of the catheter extension.Measurements of the metal cannula were taken and were found to be within specification.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 and related subassembly lots revealed no related non-conformances.A database search identified one other event associated with the reported device lot; however, this event concerns the tpn catheter not the rhcs product.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu [c_t_irhc_rev3 ] packaged with the device contains the following in relation to the reported failure mode: instructions for use section 3.) the replacement catheter end has a preloaded metal cannula.(fig.1) apply adhesive to the metal cannula.How supplied upon removal from package, inspect the product to ensure no damage has occurred.Based on the available information, inspection of the returned device, and the results of the investigation, definitive root cause was unable to be established.It is possible the ifu was not followed, but this cannot be confirmed due to lack of information regarding the procedure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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

Additional information was provided on 22sep2022.The date of event was clarified to be 02aug2022.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: phone (b)(6).E3: hospital pharmacist.Additional information: b5, e1, e3, d9 (device return).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: COOK TPN SINGLE LUMEN CATHETER REPAIR SET
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15276329
• MDR Text Key: 298406415
• Report Number: 1820334-2022-01379
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002018693
• UDI-Public: (01)00827002018693(17)200805(10)9836148
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2022

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: 08/05/2020
• Device Model Number: N/A
• Device Catalogue Number: C-RHCS-6.5
• Device Lot Number: 9836148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 09/13/2022; 11/18/2022
• Supplement Dates FDA Received: 11/04/2022; 11/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female