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

Device Problem Device Handling Problem (3265)

Patient Problem Urinary Tract Infection (2120)

Event Date 12/29/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the customer stated that their foley catheter balloon only inflated on one side and all of them, that they had been tested to do that, and they recently had multiple urinary tract infections and leakage. bd representatives confirmed with the customer that they had a 22-fr, 30cc balloon catheter and were only using 10cc to fill the balloon.They used a bard strip catheter and a catheter kit from either medline or lsl.They checked the kit and said there was a 60cc syringe in one and two 30cc syringes in the other.Also explained that they needed to use 35cc of sterile water to inflate the entire balloon to prevent leakage.After much explanation, they verbalized their understanding and stated that they had always used 10cc and always had a 30cc balloon.It was unknown what medical intervention was provided for urinary tract infection.

Event Description

It was reported that the customer stated that their foley catheter balloon only inflated on one side and all of them, that they had been tested to do that, and they recently had multiple urinary tract infections and leakage. bd representatives confirmed with the customer that they had a 22-fr, 30cc balloon catheter and were only using 10cc to fill the balloon.They used a bard strip catheter and a catheter kit from either medline or lsl.They checked the kit and said there was a 60cc syringe in one and two 30cc syringes in the other.Also explained that they needed to use 35cc of sterile water to inflate the entire balloon to prevent leakage.After much explanation, they verbalized their understanding and stated that they had always used 10cc and always had a 30cc balloon.It was unknown what medical intervention was provided for urinary tract infection.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be mishandling of device by user.A dhr review is not required as the lot number is unknown.Therefore, no additional action required at this time.Unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.H11: section a through f - 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.H3 other text: the device was not returned.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: UNKNOWN FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16162533
• MDR Text Key: 307464346
• Report Number: 1018233-2023-00082
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other