MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® LUBRICATH® FOLEY CATHETER

Model Number	365716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
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 patient has had multiple foley catheter balloons burst for the last 4-5 weeks.There was no type of patient harm involved.Per follow-up information received from ibc on (b)(6) 2022, stated that there have been 5 foley catheters in a row that had the balloon burst after insertion.Two of the catheters stayed for 3 days prior to bursting.After the last one burst, little pieces of the catheter were found in the diaper.
Additional Manufacturer Narrative
The reported event was inconclusive because poor sample condition.Based on photo attached, it was observed that the sac of catheter was burst and sac became fragmented.However, a full investigation could not be performed completely due to only photo has provided for evaluation.This complaint is inconclusive - poor sample condition and several tests could not been carried out.A potential root cause for this failure mode could be short latex dwell time, latex dip speed out too slow causing thin sac.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: caution: this product contains natural rubber latex which may cause allergic reactions.Pk6194321 4/03 rev.0 sterile unless package is opened or damaged.Do not use if package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon burst.Balloon burst can lead to premature deflation.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 patient had multiple foley catheter balloon burst for the last 4-5 weeks.There was no type of patient harm involved.Per follow-up information received from ibc on 07feb2022, stated that there have been 5 foley catheters in a row that had the balloon burst after insertion.Two of the catheters stays for 3 days prior to bursting.There were no missing pieces of the balloon for the first four foley catheters balloon burst incidents.After the last one burst, little pieces of the catheter were found in the diaper.

• Brand Name: BARD® LUBRICATH® 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: 13661275
• Report Number: 1018233-2022-01020
• Device Sequence Number: 5170549
• Product Code: EZC
• UDI-Device Identifier: 00801741077746
• UDI-Public: (01)00801741077746
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• 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: Health Professional
• Device Model Number: 365716
• Device Catalogue Number: 365716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/27/2022
• 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