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

Catalog Number UNKNOWN

Device Problems Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Discomfort (2330)

Event Date 11/14/2020

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 the slim, red catheter had been inserting only half-way for the last four days.The patient was still able to urinate but was not comfortable.The patient was using lubricant and was standing up as straight as possible when attempting to insert the catheter.Hx: per follow up via phone on 19nov2020, the patient had a swollen prostate hence the catheter was unable to insert all the way.The customer did not get the catheter inserted beyond the prostate to the bladder.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be due to tortuous anatomy (enlarged prostate).The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore bd was unable to determine the associated labeling to review.Correction: d, e, f.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.

Event Description

It was reported that the slim red catheter was inserted only half way for the last four days.The patient was still able to urinate but was not comfortable.The patient was using the lubricant and standing up as straight as possible when attempting to insert the catheter.Per follow up via phone on (b)(6) 2020 the patient had a swollen prostate hence the catheter was unable to insert all the way.The customer added that the patient did not get the catheter inserted beyond the prostate to the bladder.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: UNKNOWN LATEX FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10972422
• MDR Text Key: 220687051
• Report Number: 1018233-2020-21526
• 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: 05/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other