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

Model Number	947316
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
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 two silicone foley catheter balloon were popped.Per follow up received via email on (b)(6) 2021, customer stated that the balloon was not inflated prior to insertion on any of the foley catheters and the incident happened at the time of insertion when the nurse injected 10cc of fluid into the balloon.The nurse discarded both failed foleys as they were inside the patient at the time of failure.
Additional Manufacturer Narrative
The reported event was inconclusive since the original sample was not returned.Visual evaluation of the returned sample noted two unopened (with original packaging), lubri-sil foley catheter tray.Visual inspection of the sample noted no obvious visible defects.Investigation is inconclusive due to the original sample not returned.A potential root cause for this failure mode could be ¿ balloon damage (balloon deflates, balloon burst, balloon pinholes)¿.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labelling could not have prevented the reported failure.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 original sample was not returned.
Event or Problem Description
It was reported that two silicone foley catheter balloon were popped.Per follow-up information received via email on 02oct2021, it was stated that the customer did not inflate any of the foley catheter balloon prior to the insertion and also stated that the incident happened at the time of insertion when the nurse injected 10cc of fluid into the balloon.The nurse discarded both failed foley's as they were inside the patient at the time of failure.Per additional information received via email on 24nov2021, stated that both the catheters were inserted into the patient and the bulb burst when they inflated.They were not in use, as they had just come from the package and had not been indwelling for any period of time.

• Brand Name: BARDEX® LUBRI-SIL® 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12568172
• Report Number: 1018233-2021-06155
• Device Sequence Number: 19901146
• Product Code: EZL
• UDI-Device Identifier: 00801741024931
• UDI-Public: (01)00801741024931
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: 947316
• Device Catalogue Number: 175816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 04/11/2022
• 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