MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD DURASAFE¿ COMBINED ANESTHESIA KIT; ANESTHESIA COMBINED SPINAL & EPIDURAL KIT

Catalog Number 400713

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd durasafe¿ combined anesthesia kit there was an issue with foreign matter.

Event Description

It was reported with the use of the bd durasafe combined anesthesia kit there was an issue with foreign matter.

Manufacturer Narrative

A device history review was conducted for lot number 7226559.Our records show it was manufactured in aug- 2017, and determined that this is the second instance of a damaged packaging occurring in this lot.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections of packaged goods.With the photo submitted by the facility bd engineers were able to identify a possible fracture in the webbing of the packaging.Additionally a review of our manufacturing process determined that this originates in the supplied raw materials.Bd contacted our supplier, they confirmed the root cause is related to their manufacturing process.In response they have notified the appropriate personnel in an effort to prevent the reoccurrence of this event.Bd will continue to track and trend for this issue.

• Brand Name: BD DURASAFE¿ COMBINED ANESTHESIA KIT
• Type of Device: ANESTHESIA COMBINED SPINAL & EPIDURAL KIT
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8134883
• MDR Text Key: 129581110
• Report Number: 9610847-2018-00419
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K932249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: 400713
• Device Lot Number: 7226559
• Date Manufacturer Received: 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other