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

Catalog Number 400714

Device Problem Chemical Spillage (2894)

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

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a piece of the bd durasafe¿ anesthesia kit was damaged, and caused a spill of the medication.There was no report of exposure, injury or medical intervention.

Event Description

It was reported that a piece of the bd durasafe¿ anesthesia kit was damaged, and caused a spill of the medication.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: a device history record review was performed for the lot number 8044751 identified in the complaint which indicates that 2670 kits were manufactured.According o the documented records , the product was manufactured according to the approved manufacturing procedures, specifications and then released by quality assurance.There were no nonconformance's, capa;s or abnormal conditions noted at the time of production.At the time of the device history review there were no changes to the process and/or equipment that would have adduced the manufacturing of the device.Unfortunately without the physical sample available to inspect for damage the root cause could not be finalized.Bd will continue to track and trend for this issue.Investigation conclusion: we are unable to establish how the reported damage occurred because during process assessment no found activities that could cause this type of failure mode; the cause for the reported issue could not be conclusively determined at the manufactured site bd (b)(4).

• Brand Name: BD DURASAFE¿ ANESTHESIA KIT
• 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
• MDR Report Key: 7599179
• MDR Text Key: 111446141
• Report Number: 9610847-2018-00169
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: 400714
• Device Lot Number: 8044751
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other