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

Catalog Number	165810
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Skin Tears (2516); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the foley catheters were flimsy and bending with resistance ((b)(4) and (b)(4)).Additionally, the balloon seemed to be larger ((b)(4) and (b)(4)) and was not deflating all the way resulting in tears and bleeding ((b)(4) and (b)(4)).No medical intervention was reported.
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 foley catheters were flimsy and bending with resistance (pcn#165808 and pcn#165810).Additionally, the balloon seemed to be larger (pcn#165808 and pcn#165810) and was not deflating all the way resulting in tears and bleeding (pcn#165808 and pcn#165810).Medical intervention was unknown.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be due to "incorrect balloon design (balloon wall thickness excessive) ".The dhr review could not be performed as lot provided in the complaint was invalid.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure.That all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." 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.

• Brand Name: BARDEX® PEDIATRIC ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY 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: 18072567
• Report Number: 1018233-2023-07796
• Device Sequence Number: 7759600
• Product Code: KOD
• UDI-Device Identifier: 00801741029721
• UDI-Public: (01)00801741029721
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K821745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 165810
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/28/2023
• 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 Sex: Unknown