MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. ANESTHESIA KIT PERISAFE VI CAL 18 ANESTHESIA CONDUCTION KIT

Catalog Number 400722

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).

Event Description

It was reported that anesthesia kit perisafe vi cal 18 was damaged, but still operable. The following information was provided by the initial reporter: "(b)(6) 2020: the locking equipment delivered by plarre was sealed, a mixed block was placed with the introduction of an epidural catheter by a tohuy needle without complications at the time of removal of the tohuy needle, resistance was perceived, and a defect was observed in catheter in the distal portion, so it was decided not to force the catheter and total removal of the equipment. As immediate actions, the equipment was removed without forcing an epidural catheter together with a tohuy needle, leaving the procedure without a backup dose for analgesia, mentioning that the defect had a great potential for risk to life and complications for this patient. Product data: material: (b)(4), description: block kit 18 perisafe vi bd, lot: 9246162. ".

• Brand Name: ANESTHESIA KIT PERISAFE VI CAL 18
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10591227
• MDR Text Key: 214379476
• Report Number: 9610847-2020-00300
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 400722
• Device Lot Number: 9246162
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/27/2020 Patient Sequence Number: 1