MAUDE Adverse Event Report: COOK INC ANGLED TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number G14587

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Occupation: sterile processing manager.Pma/510k # pre-amendment.The device has been evaluated, however the investigation has not been completed.A follow up report , including an evaluation summary, will be submitted once the investigation has been completed.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 packaging for an angled tip ureteral catheter was observed to have a package that was already opened."the issue was discovered while counting stock or something similar--not grabbed for a procedure at all".The device was returned and device failure analysis determined that the bottom of the packaging was open and that it did not contain a seal.There was no evidence of a seal mark or that the package had been sealed and opened after the packaging process.There was no patient involvement.

Event Description

No additional information has been received about the event since the last report was submitted on (b)(6) 2019.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review device history record, manufacturing instructions, and quality control data.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.Inspection of the returned package contents confirmed one wire guide holder with a wire guide and one product protector with a 050010-adapter secured in the end of the protected positioned at the chevron seal.The catheter was not inside the protector or returned with the package.The bottom of the package was open and did not have a seal.There is no seal mark or evidence the package was sealed and then opened after the packaging process.A review of the device history record found no non-conformances related to the reported failure mode.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 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 relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually inspected by quality control and no related gaps in production or processing controls were noted.The returned packaging from the customer was inspected and was found to be missing a bottom seal.There is no seal mark or evidence the package was sealed and then opened post packaging process.There have been no other complaints reported for the same lot at the time of this investigation.The cause of the complaint was traced to manufacturing.Quality controls are in place for the packaging sealer machine.Most probable cause of this failure mode has been contributed to a packaging event.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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.

• Brand Name: ANGLED TIP URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8852995
• MDR Text Key: 154118525
• Report Number: 1820334-2019-01910
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002145870
• UDI-Public: (01)00827002145870(17)220402(10)9637134
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/02/2022
• Device Model Number: G14587
• Device Catalogue Number: 023106
• Device Lot Number: 9637134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1