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

Catalog Number	023106
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.Pma/510k # preamendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, prior to opening the package of the angled tip ureteral catheter, there was a light brown hair inside package.No patient involvement.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was performed including a review of complaint history, the device history record, quality control data, and specifications.One unopened package labeled rpn 023106 with label lot number 8653699 was received.Visual examination of the package confirmed a long dark hair loose inside the sealed package.The device history record was reviewed and no non-conformances were noted that may have contributed to this incident.A search of complaint records revealed this is the only complaint associated with complaint lot number 8653699.This complaint is confirmed based on the returned device.The cause has been traced to manufacturing; a quality control deficiency.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is warranted.
Event or Problem Description
There has been no new information received since the last report was submitted.

• Brand Name: ANGLED TIP URETERAL CATHETER
• Common Device Name: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7781020
• Report Number: 1820334-2018-02412
• Device Sequence Number: 1259030
• Product Code: GBL
• UDI-Device Identifier: 00827002145870
• UDI-Public: (01)00827002145870(17)210308(10)8653699
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2021
• Device Catalogue Number: 023106
• Device Lot Number: 8653699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1