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

Model Number	233624
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2019
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 end tip of the stent was embrittled and broken prior to use.
Additional Manufacturer Narrative
The reported event was confirmed.The device did not met specifications.The product was used for treatment purposes.The product was influenced by the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), fluoro-4 silicone ureteral stent.Visual inspection of the sample noted a piece measuring 1.0085 inches piece broken off the end of the stent.Additionally, the stent appeared to be broken at the eyelet location.These breaks were both out of specification per inspection procedure, which states, "no components are to be missing or damaged." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical problems and applicable local, state, and federal laws and regulations." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿incorrect process parameters.¿ h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the end tip of the stent was embrittled and broken prior to use.

• Brand Name: BARD® FLUORO-4¿ SILICONE URETERAL STENT
• Common Device Name: FLUORO STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9117645
• Report Number: 1018233-2019-05929
• Device Sequence Number: 437808
• Product Code: FAD
• UDI-Device Identifier: 10801741011679
• UDI-Public: (01)10801741011679
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: 08/31/2021
• Device Model Number: 233624
• Device Catalogue Number: 233624
• Device Lot Number: NGCTX226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1