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

Catalog Number 0165V16S

Device Problems Device Handling Problem (3265); Illegible Information (4050)

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

Event Date 12/16/2020

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 latex symbol was unclear on all bard catheters and was the same color as the other text and symbols on the packaging.It was also reported that a patient with a latex allergy received a catheter containing latex as a result.Patient had allergic reaction, pain, blood and discharge.

Event Description

It was reported that the latex symbol was unclear on all bard catheters and was the same color as the other text and symbols on the packaging.It was also reported that a patient with a latex allergy received a catheter containing latex as a result.Patient had allergic reaction, pain, blood and discharge.

Manufacturer Narrative

The reported event was confirmed as use related.No sample was returned for evaluation.According to the event a latex device was used on a patient with a latex allergy.The customer did not notice the latex warning until the device had been used on the patient and alleged that the label contain the same color contributed to the event.However, it was found that this warning was on more than one label and as the customer could see the label ,color did not play a factor.A potential root cause for the event could be due to "user deviation from instructions for use".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "contains or presence of natural rubber latex.Caution: this product contains natural rubber latex which may cause allergic reactions." correction: b.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: BARDEX SILICONE COATED FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11132031
• MDR Text Key: 225534409
• Report Number: 1018233-2020-22381
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0165V16S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other