MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD 5CC SILICONE ELASTOMER-COATED LATEX FOLEY CATHETER, NONRIBBED

Model Number	265724
Health Effect - Clinical Code	No Information (3190)
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 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 after attempting to inject 10cc of water, the catheter balloon would not completely inflate.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received 2 foley catheters in packaging, 1 opened, 1 unopened.Visually inspected the exterior of the samples and did not find any evidence of a failure that would support the reported event.Per the functional evaluation, the samples met specification, as the specification is that the catheter be able to inflate and deflate without difficulty.The following results were obtained: tested using lab syringe, inflated the balloon with 10cc water using normal fill technique and the balloon inflated without difficulty in 12sec and 5sec and the inflation funnel did not balloon out during inflation.Deflated and re-inflated the balloon with quick fill technique and the balloon inflated without difficulty and the inflation funnel did not balloon out during inflation.Dissected and did not find anything to contribute to the reported problem.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use 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.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact and adequately trained professional for assistance, as directed by hospital protocol." (b)(4).
Event or Problem Description
It was reported that after attempting to inject 10cc of water, the catheter balloon would not completely inflate.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received 2 foley catheters in packaging, 1 opened, 1 unopened.Visually inspected the exterior of the samples and did not find any evidence of a failure that would support the reported event.Per the functional evaluation, the samples met specification, as the specification is that the catheter be able to inflate and deflate without difficulty.The following results were obtained: tested using lab syringe, inflated the balloon with 10cc water using normal fill technique and the balloon inflated without difficulty in 12sec and 5sec and the inflation funnel did not balloon out during inflation.Deflated and re-inflated the balloon with quick fill technique and the balloon inflated without difficulty and the inflation funnel did not balloon out during inflation.Dissected and did not find anything to contribute to the reported problem.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use 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.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact and adequately trained professional for assistance, as directed by hospital protocol." (b)(4).
Event or Problem Description
It was reported that after attempting to inject 10cc of water, the catheter balloon would not completely inflate.

• Brand Name: BARD 5CC SILICONE ELASTOMER-COATED LATEX FOLEY CATHETER, NONRIBBED
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot 57c; covington GA 30014
• MDR Report Key: 6739163
• Report Number: 1018233-2017-03890
• Device Sequence Number: 16453034
• Product Code: EZC
• UDI-Device Identifier: 00801741039638
• UDI-Public: (01)00801741039638
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2018

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: 06/30/2017
• Device Model Number: 265724
• Device Catalogue Number: 265724
• Device Lot Number: 2EZ0079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 02/23/2018; 02/23/2018
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 02/24/2018; 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1