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

Model Number	365718
Health Effect - Clinical Codes	Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
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 balloon on the foley catheter would not deflate.The complainant reported that they attempted to siphon the fluid from the balloon port but was unsuccessful.The balloon port was reportedly then completely cut with a pair of scissors but the balloon did not deflate.The complainant reported that a wire was passed up through the balloon port but the balloon still would not deflate.A syringe was then connected to the urine drain port of the catheter and pulled back, the fluid then started to drip from the balloon port and the balloon ultimately deflated.
Additional Manufacturer Narrative
The evaluation found that the returned catheter had no pinch or blockage.Water was able to be introduced into the catheter without difficulty.No conditions found on the sample that could be associated with the reported event.The potential root cause for this failure mode could be user related (example: over aspirated, incorrect syringe)/collapse lumen/sac close eye/valve damage.Due to poor condition of the returned sample, a complete evaluation could not be performed.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.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.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.".
Event or Problem Description
It was reported that the balloon on the foley catheter would not deflate.The complainant reported that they attempted to siphon the fluid from the balloon port but was unsuccessful.The balloon port was reportedly then completely cut with a pair of scissors but the balloon did not deflate.The complainant reported that a wire was passed up through the balloon port but the balloon still would not deflate.A syringe was then connected to the urine drain port of the catheter and pulled back, the fluid then started to drip from the balloon port and the balloon ultimately deflated.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.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 the balloon on the foley catheter would not deflate.The complainant reported that they attempted to siphon the fluid from the balloon port but was unsuccessful.The balloon port was reportedly then completely cut with a pair of scissors but the balloon did not deflate.The complainant reported that a wire was passed up through the balloon port but the balloon still would not deflate.A syringe was then connected to the urine drain port of the catheter and pulled back, the fluid then started to drip from the balloon port and the balloon ultimately deflated.

• Brand Name: BARD® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9293389
• Report Number: 1018233-2019-07139
• Device Sequence Number: 2245188
• Product Code: EZC
• UDI-Device Identifier: 00801741077753
• UDI-Public: (01)00801741077753
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 365718
• Device Catalogue Number: 365718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/28/2019; 11/28/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 11/08/2019; 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention