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 Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

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 during a procedure, a redo single lumen tpn catheter was found to be faulty.The faulty line was removed and replaced on (b)(6) 2019 with a new one.Additional information regarding the device and procedure has been requested but is unavailable at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d10 - product received on.Investigation - evaluation a review of the documentation including the drawing, manufacturing instructions (mi), quality control and specifications, as well as a visual inspection of the returned device was conducted during the investigation.One redo single lumen tpn catheter set was returned to cook for investigation.A visual inspection found the female luer lock adapter to be separated from the wing fitting on the device, where the two components are bonded together.The adhesive appears to have pulled away.Additionally, a document-based investigation evaluation was performed.There is no evidence to suggest that the product was not manufactured to specification.It was concluded that the device aspect in question was visually and functionally inspected by quality control and no related gaps in production or processing controls were noted.A review of the device history record (dhr) for the complaint lot (9120209) revealed no other non-conformances.A database search found this to be the only complaint associated with the complaint lot number.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no additional device related complaints from the same lot that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "how supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred." the complaint was able to be confirmed based on inspection of the returned device along with customer testimony.Based on the information provided, inspection of the returned product, and the results of our investigation, a definitive root cause could not be determined.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.

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 an updated customer complaint form was received on 31oct2019.It was reported that the device was "placed in patient in ir".It was also reported that the patient was back on the ward when the line broke off.No other adverse effects have been reported for this incident.

• 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: 9124988
• MDR Text Key: 162351074
• Report Number: 1820334-2019-02430
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002079335
• UDI-Public: (01)00827002079335(17)210906(10)9120209
• Combination Product (y/n): N
• PMA/PMN Number: K950118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2019

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: 09/06/2021
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-6.5-90-REDO
• Device Lot Number: 9120209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 10/31/2019; 11/25/2019
• Supplement Dates FDA Received: 11/06/2019; 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention