MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEXLUBRICATH FOLEY CATHETER ALCOCK MODEL; FOLEY CATHETER (LATEX)

Model Number	0134L20
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2020
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 catheter fell out after the placement.
Event or Problem Description
It was reported that the catheter fell out after the placement.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.An amber 3 way lubricath catheter was returned without its original packaging.The catheter appeared to have white residue stuck to the shaft.The catheter was attempted to be inflated with 35 ccs of di water.A leak was noted from the whistle tip indicative of a lumen to lumen leak.A potential root cause for this failure could be "insufficient drying".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed as the reported event was a manufacturing related failure that could not be detected during initial visual inspection.The reported event was unlikely to be caused by the user.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.

• Brand Name: BARDEXLUBRICATH FOLEY CATHETER ALCOCK MODEL
• Common Device Name: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10555496
• Report Number: 1018233-2020-06054
• Device Sequence Number: 571962
• Product Code: KOD
• UDI-Device Identifier: 00801741018763
• UDI-Public: (01)00801741018763
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: 06/18/2024
• Device Model Number: 0134L20
• Device Catalogue Number: 0134L20
• Device Lot Number: MCDT4142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1