MAUDE Adverse Event Report: COOK INC BANDER URETERAL DIVERSION STENT SET; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Catalog Number	025806-S1
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: preamendment.The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported prior to use, foreign matter (like dust) was sealed in the package.Another device of the same lot was used instead to complete the procedure.No adverse effects or consequences were reported to the patient due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: investigation methods used include a review of specifications and a visual inspection of the returned device.One unopened package labeled rpn 025806-s1 and label lot number 8254264 was received.Black foreign matter of unknown origin was confirmed inside the sealed package.The complaint was confirmed.Based on the evidence presented by the sample, this event has been contributed to a manufacturing event.Cook medical will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: BANDER URETERAL DIVERSION STENT SET
• Common Device Name: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7174958
• Report Number: 1820334-2018-00020
• Device Sequence Number: 16167302
• Product Code: GBL
• UDI-Device Identifier: 00827002168176
• UDI-Public: (01)00827002168176(17)200928(10)8254264
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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 Catalogue Number: 025806-S1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/25/2017
• Supplement Date Received by Manufacturer: 12/25/2017
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1