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

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

It was reported that the patient ordered foley catheter and the current lot# received were not the correct size.Per additional information received via phone on 13nov2023, customer experienced a sizing issue.Customer thought that the foley catheter was smaller than they have been before, the packaging said 28 but customer felt they were getting 26.Customer stated that this was frequently happening to where they had at least one the wrong size from every order, but this order customer had about 8 of them.Customer stated that they were all from the same lot.

Manufacturer Narrative

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

It was reported that the patient ordered foley catheter and the current lot# received were not the correct size.Per additional information received via phone on (b)(6) 2023, customer experienced a sizing issue.Customer thought that the foley catheter was smaller than they have been before, the packaging said 28 but customer felt they were getting 26.Customer stated that this was frequently happening to where they had at least one the wrong size from every order, but this order customer had about 8 of them.Customer stated that they were all from the same lot.Per additional information received on (b)(6) 2023, it was reported that the foley catheter was painful at insertion site and bloody and swollen.No medical intervention was reported.Per additional information received on (b)(6) 2023, the catheter was causing a severe irritation pain inside my bladder.They did not know if that was also causing the redness externally or if the redness was caused by some sort if skin irritation from the catheter.No medical intervention was reported.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.Visual evaluation of the returned sample noted two opened (without original packaging), used foley catheters and one foley catheter cut in half.Visual inspection of the sample noted the two foley catheter was measured (0.33").The one cut in half catheter was unable to be measured.No root cause could be found because the reported event was unconfirmed.The lot number is unknown; therefore, the device history record could not be reviewed.As the reported event is unconfirmed a labeling review is not required.Correction: a,d,e.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.H3 other text : the actual/suspected device was inspected.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: LATEX 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: 18227016
• MDR Text Key: 329241701
• Report Number: 1018233-2023-08619
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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