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

Model Number	G14274
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510k #: preamendment.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
As reported, prior to distribution to a user facility the distributor found foreign matter inside the unopened package of a open-end ureteral catheter.This device did not make patient contact.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable additional information: d10.Investigation ¿ evaluation.A review of complaint history, device history record , quality controls, and a visual inspection were conducted during the investigation.One unopened device was returned for investigation.The returned packaging confirms the reported complaint device lot number.The visual examination confirmed dark colored fibrous foreign matter that was free floating inside of the sealed package.Additionally, a document based investigation evaluation was performed.A search of the complaint database revealed no other complaints related to this lot number.The device history record was reviewed and no non-conformances were found during the production of this lot number.The cause for the foreign matter was contributed to a packaging event.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.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 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 or Problem Description
There is no new patient or event information to be reported.

• Brand Name: OPEN-END 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: 8816789
• Report Number: 1820334-2019-01760
• Device Sequence Number: 2348560
• Product Code: GBL
• UDI-Device Identifier: 00827002142749
• UDI-Public: (01)00827002142749(17)220328(10)9627372
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 03/28/2022
• Device Model Number: G14274
• Device Catalogue Number: 020015
• Device Lot Number: 9627372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1