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

Model Number	0165PL08
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2018
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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that water could not be injected into the balloon and the balloon could not be inflated during a pretest.
Event or Problem Description
It was reported that water could not be injected into the balloon and the balloon could not be inflated during a pretest.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received only the catheter for evaluation.The exterior of the sample was visually inspected and did not find any evidence of a failure that would support the reported event.The functional evaluation found that the catheter could be inflated without difficulty.The catheter was dissected and found no conditions that would contribute to the reported problem.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "1.Method of use insert catheter into the urethral meatus and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a syringe packaged in the tray, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.".

• Brand Name: BARDEX® LUBRICATH® PEDIATRIC FOLEY CATHETER
• Common Device Name: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7481490
• Report Number: 1018233-2018-01447
• Device Sequence Number: 19113792
• Product Code: EZC
• UDI-Device Identifier: 00801741017667
• UDI-Public: (01)00801741017667
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 03/01/2022
• Device Model Number: 0165PL08
• Device Catalogue Number: 0165PL08
• Device Lot Number: 7DA0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1