MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL SILICONE TRICOT 25BX; STATLOCK FOLEY

Model Number FOL0102

Device Problem Component Missing (2306)

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

Event Date 02/12/2021

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 5 pieces were missing in 1 box.Per follow up on 17feb21, it was indicated that the material was missing from shipping box and therefore not used on patient.Also, stated that it was not a separated component that is missing.From a shipping box (with 25 units, according to sap), it was missing 5 units, customer received only 20 units.

Manufacturer Narrative

The reported event was inconclusive due to the poor sample condition.Visual inspection noted two photo samples were received.Visual evaluation noted one photo showed a single statlock package and the second photo showed the bulk package.Based on the photos received the reported event was unable to be confirmed.A potential root cause for this failure mode could be due to operator error.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed due to the labeling could not have prevented the reported failure.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.

Event Description

It was reported that the 5 pieces were missing in 1 box.Per additional information received via email from the ibc on 17feb2021 the device was not used on a patient since the material was missing from the shipping box.It was not a separated component that was missing.From a shipping box (with 25 units according to sap) it was reported that 5 pieces were missing customer only received 20 units.

• Brand Name: SL FOLEY SWIVEL SILICONE TRICOT 25BX
• Type of Device: STATLOCK FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11446220
• MDR Text Key: 238841460
• Report Number: 1018233-2021-01141
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076114
• UDI-Public: (01)00801741076114
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: FOL0102
• Device Catalogue Number: FOL0102
• Device Lot Number: JUEX2169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other