MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALL SILICONE CATHETER

Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/04/2023
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.H11: section a through f - the information provided by bd represents all 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 customer was having an issue when the balloon was being deflated the balloon material was not flattening out and there was a hard ridge/ring.It caused significant pain when removing the catheter.They had this happen in 3 patients with 3 different nurses over 24 hours.They were able to replicate it with a new catheter for a few times and then once the balloon was stretched out well, they were no longer able to replicate.They had used these catheters for a long time and none of the nurses remember this happening before.Per follow up via email on 08aug2023, customer stated that one patient was a lot more difficult to remove and the others just had the pain.Also stated that they were not sure if all of the catheters were from the same lot.The staff pulled back on the syringe to deflate the balloon and had one sample saved to send for evaluation.Also had 2 of the patients information.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿incorrect balloon design¿.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.Corrections: d h11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the customer was having an issue when the balloon was being deflated the balloon material was not flattening out and there was a hard ridge/ring.(pr# 8598349) it caused significant pain when removing the catheter.They had this happen in 3 patients with 3 different nurses over 24 hours.(pr# 8597490) they were able to replicate it with a new catheter for a few times and then once the balloon was stretched out well, they were no longer able to replicate.They had used these catheters for a long time and none of the nurses remember this happening before.Per follow up via email on (b)(6) 2023, customer stated that one patient was a lot more difficult to remove and the others just had the pain.Also stated that they were not sure if all of the catheters were from the same lot.The staff pulled back on the syringe to deflate the balloon and had one sample saved to send for evaluation.Also had 2 of the patients information.

• Brand Name: ALL SILICONE CATHETER
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17630540
• Report Number: 1018233-2023-06354
• Device Sequence Number: 14300386
• Product Code: NZU
• UDI-Device Identifier: 00801741143083
• UDI-Public: (01)00801741143083
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023
• 2 Devices were Involved in the Event: 1 2

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Male