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	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Patient code: no patient involvement.Device code: foreign material present in device is not labeled.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
It was reported that the distributer found that there was a black foreign matter in the package.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: investigation methods used include a review of complaint history, the device history record, specifications, and a visual inspection of the returned device.One unopened bander ureteral diversion stent set package was returned for investigation.A visual examination of the returned package confirmed a black o-ring loose inside the packaging tray within the sealed package.All three fittings in the set were disassembled confirming o rings present in each connector.Based on the evidence presented by the sample, this event has been contributed to a packaging error.A review of the device history record was performed.A non-conformance was identified for a component missing.The description indicates that the component missing was a black o-ring.This missing o-ring appears to be what was in the returned complaint product.A review of complaint history for this device/lot combination revealed there have been no other complaints for this issue received against lot number 8545718.Based on the information provided and results of the investigation, the cause of this issue is manufacturing related.The relevant personnel in manufacturing were informed of this complaint.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.

• 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: 7406754
• Report Number: 1820334-2018-00957
• Device Sequence Number: 1607969
• Product Code: GBL
• UDI-Device Identifier: 00827002168176
• UDI-Public: (01)00827002168176(17)210129(10)8545718
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 05/07/2018

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: 04/02/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1