MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD FLUORO-4 SILICONE URETERAL COIL STENT

Model Number	277405
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the flouro-4 silicone ureteral stent was found to be broken when the package was open.
Event or Problem Description
It was reported that the flouro-4 silicone ureteral stent was found to be broken when the package was open.
Additional Manufacturer Narrative
The reported event was confirmed, however the cause was unknown.The device was not used for the treatment.The device had not met specifications.The device was affected by the reported failure.Visual evaluation of the returned sample noted that one opened (with original packaging), unused fluoro 4 coil stent.It was noted that the stent had been broken near the 4-shaped end.This does not meet the specification "no components are to be missing or damaged".Although the reported event was confirmed, the root cause could not be determined.A potential root cause of this failure could be due to lack of training.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed due to the labelling could not have prevented the reported failure.

• Brand Name: BARD FLUORO-4 SILICONE URETERAL COIL STENT
• Common Device Name: STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10122547
• Report Number: 1018233-2020-03598
• Device Sequence Number: 1800059
• Product Code: FAD
• UDI-Device Identifier: 10801741011747
• UDI-Public: (01)10801741011747
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K823487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: Other
• Device Expiration Date: 08/31/2021
• Device Model Number: 277405
• Device Catalogue Number: 277405
• Device Lot Number: NGCV1592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1