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

Model Number	01267522
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2020
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 balloon of the catheter slightly inflated before use.Per sample evaluation, it was found that one of the catheters had a dented balloon and four catheters could not completely deflate.
Additional Manufacturer Narrative
The reported event was confirmed.Visual inspection noted 24 unopened foley catheters were received.The 24 catheters were inflated with 75 ccs of water using a 20 cc syringe the water was unable to deflate.As the samples were returned unopened they did not appear to be used for the treatment or diagnosis.The catheters were found to unable to deflate there appears to be a relationship between the reported event and the device.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event was found to be confirmed as manufacturing related, a labeling review was not required.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 actual/suspected device was inspected.
Event or Problem Description
It was reported that the balloon of the catheter slightly inflated before use.Per sample evaluation, it was found that one of the catheters had a dented balloon and four catheters could not completely deflate.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER CREEVY MODEL
• Common Device Name: FOLEY CATHETER CREEVY MODEL
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10737685
• Report Number: 1018233-2020-20449
• Device Sequence Number: 11591310
• Product Code: EZC
• UDI-Device Identifier: 00801741018817
• UDI-Public: (01)00801741018817
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K910195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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 Expiration Date: 05/31/2024
• Device Model Number: 01267522
• Device Catalogue Number: 01267522
• Device Lot Number: NGDW3341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 05/11/2021
• 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