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

Catalog Number 400273

Device Problem Leak/Splash (1354)

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

Event Date 11/11/2022

Event Type  malfunction  

Event Description

It was reported while using (brand name) leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: leak during injection pressure with a 5ml syringe.

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.

Manufacturer Narrative

The following fields were updated due to additional information: b5: describe event or problem: it was reported while using bd perisafe¿ epidural mini-kit leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: leak during injection pressure with a 5ml syringe.D10: device available for eval yes.D10: returned to manufacturer on: 16-dec-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.

Event Description

It was reported while using bd perisafe¿ epidural mini-kit leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: leak during injection pressure with a 5ml syringe.

• Brand Name: BD PERISAFE¿ EPIDURAL MINI-KIT
• Type of Device: 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: 15929826
• MDR Text Key: 304962476
• Report Number: 2618282-2022-00088
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 50382904002737
• UDI-Public: 00382904002732
• Combination Product (y/n): N
• Reporter Country Code: TS
• PMA/PMN Number: K953790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400273
• Device Lot Number: 0036486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1