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

Model Number	A304918
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 foley balloon would not flush.Upon removal, the device was found mushroomed and as a result, there was blood in the urine output.No medical intervention was reported.
Event or Problem Description
It was reported that the foley balloon would not flush.Upon removal, the device was found mushroomed and as a result, there was blood in the urine output.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one silicone foley catheter with no original packaging present.Visual inspection of the catheter surface noted no obvious defects.A small ridge was noted on the balloon surface upon sample receipt.The catheter balloon was inflated with 10ml of methylene blue and water solution and allowed to rest for 30 minutes with no leaks.The balloon passively deflated all 10ml with no issues.No cuffing was noted and balloon concentricity was observed to be 60:40.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿to deflate catheter balloon: gently insert a luer slip tip 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." 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.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Common Device Name: BARDEX FOELY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8271516
• Report Number: 1018233-2019-00402
• Device Sequence Number: 16548440
• Product Code: EZL
• UDI-Device Identifier: 00801741100499
• UDI-Public: (01)00801741100499
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K984084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 08/13/2023
• Device Model Number: A304918
• Device Catalogue Number: 175814
• Device Lot Number: NGCU0126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1