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

Catalog Number	025706-S1
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: pre-amendment.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
When the device arrived at the hospital, it was noted that there was an unidentified foreign matter sealed inside the sterile pouch.Therefore, it was replaced with another 025706-s1.This product was not used on a patient.
Additional Manufacturer Narrative
H6 ¿ results codes: 4244, packaging contains unintended material.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, and quality control data.One unopened package labeled rpn 025706-s1 with label lot number 8754583 was received.A visual examination of the sealed package confirmed black fuzz like foreign matter trapped inside the package.The device history lot record noted there were no non-conformances associated with the complaint device lot number.A search of complaint records found this is the only complaint associated with lot number 8754583.A document review identified that there was a quality control inspection procedure in place to inspect for foreign matter on 100% of product after being packaged.The cause of this complaint is manufacturing related.Measures are in process to address the issue of foreign matter.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
When the device arrived at the hospital, it was noted that there was an unidentified foreign matter sealed inside the sterilisation pouch.Therefore, it was replaced with another 025706-s1.

• 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: 7659397
• Report Number: 1820334-2018-01982
• Device Sequence Number: 16557222
• Product Code: GBL
• UDI-Device Identifier: 00827002168183
• UDI-Public: (01)00827002168183(17)210405(10)8754583
• 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): 08/01/2018

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: 04/05/2021
• Device Catalogue Number: 025706-S1
• Device Lot Number: 8754583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1