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

Model Number FOL0102

Device Problem Incorrect Measurement (1383)

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

Event Date 06/02/2021

Event Type  malfunction  

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 stat lock was too small and did not hold or stay locked.Customer took the patient to the emergency room twice because the catheter got pulled out.Customer stated that it happened twice already.Per follow up on 11jun2021, customer stated that the catheter was too small, hence it kept coming out.Nurses stated that the catheter was changed, and everything was okay now.Also reported that patient was not using stat lock because experienced allergic to it and would get blisters.No medical intervention was reported.

Event Description

It was reported that statlock was too small and did not hold or stay locked.Customer took the patient to the emergency room twice because the catheter got pulled out.Customer stated that it happened twice already.Per follow up on 11jun2021, customer stated that the catheter was too small, hence it kept coming out.Nurses stated that the catheter was changed and everything was okay now.Also reported that patient was not using statlock because experienced allergic to it and would get blisters.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure mode could be due to user issue, operator error, mechanical failure (eg: speed controller faulty).The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling 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.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.The device was not returned.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12059685
• MDR Text Key: 258134178
• Report Number: 1018233-2021-03784
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741076114
• UDI-Public: (01)00801741076114
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/28/2022
• Device Model Number: FOL0102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other