MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bard® Lubricath® Foley Catheter

Catalog Number	365716
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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 the foley catheter balloon not deflating with syringe at port on catheter tube.Patient placed in multiple positions and still unable to deflate.Foley draining adequate amounts throughout shift.Reviewed with l&d "[labor and delivery]", suggestion made to cut tubing at inflation port.Pink port cut from catheter tube, saline drained, and catheter removed without difficulty.Patient bladder scanned post removal for 29 cc.Ob "[obstetrician]" aware.Over to assess pt.Bedside us "[ultrasound]" performed.The patient was post c/s "[cesarean section]" from this morning at 0935.Registered nurse attempted to remove her foley as ordered around 1830.Per registered nurse, the foley had been adequately draining all shift.Registered nurse unable to deflate the foley using a 10cc syringe at the pink inflation port.Registered nurse moved the patient to multiple different positions with no luck.When registered nurse went over to l&d rounds, registered nurse asked if anyone had encountered this issue before because none of us had experienced this.L&d stated that they sometimes see it prior to delivery when the baby's head was low and they usually cut the inflation port off and the saline drains, so that was what they did and the foley was able to be successfully removed after that.Unfortunately, the patient was on the toilet when the pink port was cut off, and it went into the toilet and was unable to be saved.A bladder scan was done on the patient post removal for 29 cc.Md was made aware and came over to assess the patient and did a bedside ultrasound which was wnl "[within normal limits]".

• Brand Name: Bard® Lubricath® Foley Catheter
• Common Device Name: Foley Catheter
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. Bard Inc. (Covington) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; +1(770)784-6100
• MDR Report Key: 25571638
• Report Number: 1018233-2026-04070
• Device Sequence Number: 9276949
• Product Code: EZC
• UDI-Device Identifier: 00801741077746
• UDI-Public: (01)00801741077746(11)260321(17)280531(10)NGLP2177
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 365716
• Device Lot Number: NGLP2177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 06/20/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 145 LB
• Patient Race: Asian