MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. COMPLETE CARE FOLEY TRAY

Catalog Number 900014A

Device Problem Unsealed Device Packaging (1444)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

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 seal on the boxes of the tray were not sealed correctly and was split and were no longer sterile.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inappropriate package design".It is unknown whether the device had met relevant specifications.Based on no patient involvement the product does not appear to have been used.However, the product is intended to be used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.

Event Description

It was reported that the seal on the boxes of the tray were not sealed correctly and was split and were no longer sterile.

• Brand Name: BARDEX I.C. COMPLETE CARE FOLEY TRAY
• Type of Device: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11342757
• MDR Text Key: 232357835
• Report Number: 1018233-2021-00608
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2023
• Device Catalogue Number: 900014A
• Device Lot Number: NGES1790
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other