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

Model Number	303316A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
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 a catheter prematurely deflated and a tear was noted in the balloon, approximately two hours after insertion.The catheter was inserted on (b)(6) 2019 at 0700 in the operating room, in a (b)(6) year old female undergoing a total laparoscopic hysterectomy.
Event or Problem Description
It was reported that a catheter prematurely deflated and a tear was noted in the balloon, approximately two hours after insertion.The catheter was inserted on 6/26/19 at 0700 in the operating room, in a 47 year old female undergoing a total laparoscopic hysterectomy.The catheter was placed without resistance, inflated with 10ml, and placement was confirmed with urine return.
Additional Manufacturer Narrative
The reported event was confirmed as cause unknown.Per the evaluation, a sac burst was noted along the lumen.No pieces of sac were missing.The burst location was observed along the inflation eye and the cause was unknown.A potential root cause for this failure mode could be user related (example: contact with sharp object)/ / exposure to petrolatum based products mechanical failure/operator error.How and when problem occurred could not determined and could not be classified as a manufacturing related.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: ¿caution: federal (u.Sa.) law restricts this device to sale by or on the order of a physician.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: do not aspirate urine through drainage funnel wall.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.".
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Correction: d1, 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 a catheter prematurely deflated and a tear was noted in the balloon, approximately two hours after insertion.The catheter was inserted on (b)(6) 2019 at 0700 in the operating room, in a 47 year old female undergoing a total laparoscopic hysterectomy.The catheter was placed without resistance, inflated with 10ml, and placement was confirmed with urine return.

• Brand Name: BARDEX® I.C. 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: 8798819
• Report Number: 1018233-2019-03970
• Device Sequence Number: 2693953
• Product Code: MJC
• UDI-Device Identifier: 00801741024269
• UDI-Public: (01)00801741024269
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• 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): 08/21/2019

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: 07/01/2023
• Device Model Number: 303316A
• Device Catalogue Number: 0166SI16
• Device Lot Number: NGCZ1867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 08/07/2019; 08/17/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/12/2019; 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR