MAUDE Adverse Event Report: COOK INC TRIFORCE PERIPHERAL CROSSING SET; KRA CATHETER, CONTINUOUS FLUSH

Model Number G56413

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: other non-healthcare professional: district manager.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, the outer sheath of a triforce peripheral crossing set came out of the plastic case and punctured the peel away packaging, rendering it non-sterile.The product was part of the sales rep stock, so no patient was involved.

Manufacturer Narrative

Description of event: it was reported, the outer sheath of a triforce peripheral crossing set came out of the plastic case and punctured the peel away packaging, rendering it non-sterile.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one sealed kcxs-5.0-35-65-rb-0/dav-hc to cook for investigation.Physical examination of the returned device showed that the clear film is torn at that the bottom of pouch.It is suspected that the plastic packing tray punctured the sterile pouch clear front film.There is no evidence from device failure analysis the device was manufactured out of specification.A review of the device history record found no non-conformances related to the reported failure mode.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 other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.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 to whether the product is sterile.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that the transport, storage, and handling of the complaint device contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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 new patient or event information to report.

• Brand Name: TRIFORCE PERIPHERAL CROSSING SET
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10794626
• MDR Text Key: 215058274
• Report Number: 1820334-2020-02024
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002564138
• UDI-Public: (01)00827002564138(17)221209(10)10180798
• Combination Product (y/n): N
• PMA/PMN Number: K170931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/09/2022
• Device Model Number: G56413
• Device Catalogue Number: KCXS-5.0-35-65-RB-0/DAV-HC
• Device Lot Number: 10180798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1