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

Model Number	400273
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.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 no resistance in the syringe.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: 1/no resistance at the level of the syringe piston.
Event or Problem Description
It was reported while using bd perisafe¿ epidural mini-kit there was no resistance in the syringe.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: 1/no resistance at the level of the syringe piston.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 29-nov-2022.One photo sample and one physical sample was provided to our quality team for investigation.The sample displays the material information as reported, however, there is no defect that can be identified within the sample, therefore we cannot verify the reported issue a device history review was performed for the reported lot 0036486 and no deviations or non conformances were identified during the manufacturing process that could have contributed to this issue.Based on the available information, we cannot identify a root cause at this time.H3 other text : see h10.

• 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: 15926051
• Report Number: 2618282-2022-00087
• Device Sequence Number: 5077112
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: (01)30382904002733
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• 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): 12/19/2022

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 Expiration Date: 02/28/2025
• Device Model Number: 400273
• Device Catalogue Number: 400273
• Device Lot Number: 0036486
• 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: 11/11/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2020
• 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