MAUDE Adverse Event Report: BD CARIBE LTD. BD PERISAFE¿ EPIDURAL MINI-KIT; ANESTHESIA CONDUCTION KIT

Model Number	400273
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd perisafe¿ epidural mini-kit there was a clog.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: one out of three side port is blocked when they checked outside body so they not used further.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 06-feb-2023.H6.Investigation summary: two perisafe trays (400273) were received by our quality team for investigation.Trays were empty and the components were included in a separate cylinder container.In the first cylinder the components were complete and correct.In the second cylinder the needle is not a bd component, the rest of the materials are correct, and each tray had a catheter to be evaluated.Catheters were inspected and tested for visual, dimensional, and functional characteristics, one of the three holes was clogged, therefore the incident is confirmed.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.During review of the process, possible root cause is associated to the supplier manufacturing process.
Event or Problem Description
It was reported while using bd perisafe¿ epidural mini-kit there was a clog.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: one out of three side port is blocked when they checked outside body so they not used further.

• Brand Name: BD PERISAFE¿ EPIDURAL MINI-KIT
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16203939
• Report Number: 2618282-2022-00104
• Device Sequence Number: 5627530
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: (01)30382904002733
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K953790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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: Other
• Device Model Number: 400273
• Device Catalogue Number: 400273
• Device Lot Number: 2138669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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
• Patient Sex: Unknown