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

Device Problem Missing Information (4053)

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

Event Date 09/29/2021

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 the customer had an issue with some bard foley kits where the foleys were not properly labeled with the latex warning sticker.It was stated that vet ordered for a foley placement, allergies verified no allergy to latex noted and original order read to place a 16f foley and if not successful to place a 14f foley.It was stated that when inspecting the foley catheter kits reference numbers (b)(4) for 16 french foley cath kit and (b)(4) for 14 french foley cath kit, one had a label with a warning for latex and the other did not.It was also stated that the warning label should be documented on all kits and the actual product warning was hard to see as it was on the seem of the product (material: a303316a and a303314a).Also, it was stated that if this was a patient who had an allergy they could be harmed as there were no kits without latex.

Event Description

It was reported that the customer had an issue with some bard foley kits where the foleys were not properly labeled with the latex warning sticker.It was stated that vet ordered for a foley placement, allergies verified no allergy to latex noted and original order read to place a 16f foley and if not successful to place a 14f foley.It was stated that when inspecting the foley catheter kits reference numbers a303316a for 16 french foley cath kit and a303314a for 14 french foley cath kit, one had a label with a warning for latex and the other did not.It was also stated that the warning label should be documented on all kits and the actual product warning was hard to see as it was on the seem of the product (material: a303316a and a303314a).Also, it was stated that if this was a patient who had an allergy they could be harmed as there were no kits without latex.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "missing instructions".The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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: FOLEY TRAYS
• Type of Device: FOLEY TRAYS
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12674064
• MDR Text Key: 277699628
• Report Number: 1018233-2021-06525
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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