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

Model Number 400273

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd perisafe¿ epidural mini-kit catheter needle was blocked during use while trying to perform an epidural.The following information was provided by the initial reporter: "catheter of perisafe epidural experienced block when trying to give medicine during epidural procedure.".

Event Description

It was reported that the bd perisafe¿ epidural mini-kit catheter needle was blocked during use while trying to perform an epidural.The following information was provided by the initial reporter: "catheter of perisafe epidural experienced block when trying to give medicine during epidural procedure.".

Manufacturer Narrative

H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The catheter functional, dimensional, and visual inspections were found in accordance with bd specifications.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD PERISAFE¿ EPIDURAL MINI-KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10336354
• MDR Text Key: 201705156
• Report Number: 2618282-2020-00065
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: 30382904002733
• Combination Product (y/n): N
• PMA/PMN Number: K953790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Model Number: 400273
• Device Catalogue Number: 400273
• Device Lot Number: 9030620
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2019
• 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
• Patient Outcome(s): Other