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

Model Number	0166SI20
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
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 balloons on 20 french 30 ml silver tipped non-latex catheters was deflating due to holes.
Event or Problem Description
It was reported that the balloons on 20 french 30 ml silver tipped non-latex catheters were deflated due to holes.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met relevant specifications.The product used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be due to a user related (example: contact with sharp objects/ exposed to petrolatum based products/ mechanical failure/ operator error).The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: "[contraindications] 1.Precautions for use.(1) since movement of the body, etc.May twist or bend catheter to cause occlusion care should be taken the fix the catheter securely.(2) after placement of the catheter, confirm urinary flow through the catheter.When urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.If the problem is still observed, consider catheter replacement." 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.H3 other text : the device was not returned.

• 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 30014
• MDR Report Key: 10871548
• Report Number: 1018233-2020-21075
• Device Sequence Number: 4329662
• Product Code: MJC
• UDI-Device Identifier: 00801741016868
• UDI-Public: (01)00801741016868
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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 Model Number: 0166SI20
• Device Catalogue Number: 0166SI20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 03/11/2021
• 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: Other