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

Model Number	0165V16S
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2023
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.
Event or Problem Description
It was reported that the customer had two foley catheters that have had holes in them.Per follow up received on 20-jan-2023, customer stated that the balloon would not hold fluid because it had a hole.They threw both of them away because they could not use them and now don't have enough to get them to next shipment.
Additional Manufacturer Narrative
The reported event is inconclusive due to poor sample.No physical sample was returned, however, a photo sample was submitted.Visual evaluation of the photo sample noted the unit box with ref 0165l16 and lot nggvx503, the catheter was not pictured, therefore, the photo sample could not be evaluated for the reported failure.Additionally, the material number pictured does not correspond with the material number reported.A potential root cause for this event could be, "high modulus latex".The device was used for treatment purposes.It is unknown if the device had met relevant specifications or resulted in the reported event.A dhr review is not required as the lot number is unknown.The instructions for use were found adequate and state the following: "storage: store catheters at room temperature away from direct exposure to light, preferably in the original box" "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 bard 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 bard.
Event or Problem Description
It was reported that the customer had two foley catheters that have had holes in them.Per follow up received on 20jan2023, customer stated that the balloon would not hold fluid because it had a hole.They threw both of them away because they could not use them and now don't have enough to get them to next shipment.Per follow up via phone on 18april2023, it was reported that customer no longer have that information and had since thrown all of that information away.

• Brand Name: BARDEX® SILICONE COATED 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: 16241985
• Report Number: 1018233-2023-00311
• Device Sequence Number: 17742594
• Product Code: EZC
• UDI-Device Identifier: 00801741039393
• UDI-Public: (01)00801741039393
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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 Model Number: 0165V16S
• Device Catalogue Number: 0165V16S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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