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

Model Number	0170SI14
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
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.The device was not returned.
Event or Problem Description
It was reported that the balloon of two separate catheters burst and fell out of the patient.It was stated that the second attempt to insert the catheter led to try a coude tip foley catheter.No patient injury was reported.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was used for treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used two-way coude silicone foley catheter.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), and no leaks were observed.The catheter was passively deflated with no issues noted.The device met specifications.No root cause could be found because the reported event was unconfirmed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.The device was returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event is unconfirmed a labeling review and risk review is not required.H11:section a through f - the information provided by bd 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 bd.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the balloon of two separate catheters burst and fell out of the patient.It was stated that the second attempt to insert the catheter led to try a coude tip foley catheter.No patient injury was reported.

• Brand Name: BARDEX® LUBRI-SIL® I.C. 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: 11871959
• Report Number: 1018233-2021-02997
• Device Sequence Number: 16947621
• Product Code: MJC
• UDI-Device Identifier: 00801741025334
• UDI-Public: (01)00801741025334
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K984136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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 Expiration Date: 09/30/2024
• Device Model Number: 0170SI14
• Device Catalogue Number: 0170SI14
• Device Lot Number: NGER3003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 11/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2020
• 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