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

Device Problem Incorrect Measurement (1383)

Patient Problems Pain (1994); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that there was a sizing issue noticed over the last six months.Stated that two weeks ago they received 4 foley trays and out of the 4 trays only 1 was of the correct size.They also believed that this had caused the patient a autonomic dysreflexia.The catheter was changed 4 days ago but they didn't realize that the tubing was smaller.When the patient tried to pass urine where the tube was too small, so it never allowed urine to flow.It was dripping and had started to back up to the kidneys causing pain to the patient.After a very quick catheter change they noticed that the tubes were completely different.

Event Description

It was reported that there was a sizing issue noticed over the last six months and stated that two weeks ago they received 4 foley trays and out of the 4 trays only 1 was of the correct size.They also believed that this had caused the patient a autonomic dysreflexia.The catheter was changed 4 days ago but they didn't realize that the tubing was smaller.When the patient tried to pass urine where the tube was too small, so it never allowed urine to flow.It was dripping and had started to back up to the kidneys causing pain to the patient.After a very quick catheter change they noticed that the tubes were completely different.

Manufacturer Narrative

The reported event was inconclusive due to poor sample condition.The potential root cause for this failure mode could be, ¿operator error/ mechanical error/lack of inspection/dipped undersize.¿ the lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the latex foley catheter product ifus were found to be adequate based on past reviews.Corrections: d, h.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: LATEX FOLEY CATHETER
• Type of Device: LATEX FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11195903
• MDR Text Key: 227750061
• Report Number: 1018233-2020-22598
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other