MAUDE Adverse Event Report: COOK INC OPEN-END FLEXI-TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number	G14521
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Occupation: perioperative materials manager.Pma/510k #: preamendment.Investigation evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, manufacturing instructions, and quality control data, specifications.The complainant returned one unopened package containing an open -end flexi- tip ureteral catheter for investigation.Returned packaging confirms the lot number.Visual examination confirmed a hair like fiber in the sealed package.Fiber is trapped in the edge of the bottom straight seal.Review of device history record did not observe any nonconformances that may have contributed to this incident.A trackwise search revealed this complaint to be the only one associated with complaint lot number.Based on the evidence presented by the sample, this event has been contributed to a packaging event.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.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Event or Problem Description
It was reported while preparing for an unspecified procedure using an open-end flexi-tip ureteral catheter, the customer found a hair like fiber inside the sealed package.This device was not used.The device did not make patient contact.The patient did not experience any adverse effects or require any additional procedures as a result of this occurrence.

• Brand Name: OPEN-END FLEXI-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: 8759795
• Report Number: 1820334-2019-01606
• Device Sequence Number: 11160750
• Product Code: GBL
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)220514(10)9738671
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

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: 05/14/2022
• Device Model Number: G14521
• Device Catalogue Number: 021305
• Device Lot Number: 9738671
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1