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

Model Number	806318
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 there was a prominent ridge in the balloon of the foley catheter.
Additional Manufacturer Narrative
The reported event was confirmed, however, the cause is unknown.Visual evaluation of the returned sample noted one opened (without original packaging), used (note yellow staining in tube) silicone foley catheter, medline drain bag and connected inlet tube and sample port connector (non-bard) in addition to 2 unopened catheters in original packaging (with matching lot numbers).Visual inspection of the sample noted that the opened silicone foley catheter had a prominent ridge in the catheter balloon (see original complaint).This is out of specification per inspection procedure which states, "balloon must not cuff after deflation." the catheters were removed from their sample port connector/packaging and the inner diameter of the drainage funnel end was measured for each.The inner diameter of the used catheter drainage funnel end was 0.3645 inches, and the inner diameter of the unused catheters at the drainage funnel ends were 0.3625 inches each.These values are within specification.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿balloon material does not shrink quickly enough." 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 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 the balloon fragments have been removed.Visually inspect the product for any imperfections or surface deterioration prior to use." correction: d4.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.
Event or Problem Description
It was reported that there was a prominent ridge in the balloon of the foley catheter.

• Brand Name: BARDIA® ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9497233
• Report Number: 1018233-2019-08098
• Device Sequence Number: 19681240
• Product Code: EZL
• UDI-Device Identifier: 00801741039126
• UDI-Public: (01)00801741039126
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: 04/25/2024
• Device Model Number: 806318
• Device Catalogue Number: 806318
• Device Lot Number: NGDR3627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1