MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER

Model Number	A899916
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer had 2 latex foley catheter trays that had the inner paper wrapper ripped and torn, resulting in an unsterile field for trays.The external dust covers were intact.The customer might have a bad lot.It was looked like whatever machine bard had to wrap the inside tray had an issue and grabbed part of the paper wrap and ripped a large bite out of the edge of it.It might not be seen until unwrap the tray completely and get ready to insert it.Emergency department reported that they were having an internal wrap that had the sides completely cut off.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.The potential root cause for this failure could be "inappropriate package design".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 labeling 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 or Problem Description
It was reported that the customer had 2 latex foley catheter trays that had the inner paper wrapper ripped and torn, resulting in an unsterile field for trays.The external dust covers were intact.The customer might have a bad lot.It was looked like whatever machine bard had to wrap the inside tray had an issue and grabbed part of the paper wrap and ripped a large bite out of the edge of it.It might not be seen until unwrap the tray completely and get ready to insert it.Emergency department reported that they were having an internal wrap that had the sides completely cut off.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15418921
• Report Number: 1018233-2022-07126
• Device Sequence Number: 15107907
• Product Code: EZC
• UDI-Device Identifier: 00801741074011
• UDI-Public: (01)00801741074011
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: A899916
• Device Catalogue Number: A899916
• Device Lot Number: NGGQ3719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown