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

Catalog Number 400722

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 11/27/2018

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 that an anesthesia kit perisafe vi cal 18 arrived damaged.

Manufacturer Narrative

H.6.Investigation summary: the supplier was notified related to this defect, the corrective action was sent us in april 30, 2018, and this lot was manufactured on june 2018.Incoming inspection and the supplier will be notified about this complaint to prevent recurrence of the problem.Dhr review: the device history records (dhr) review was performed for the lot number 8164995 (mfg date june 13, 2018) identified in the complaint 766536 which indicates that 2,670 kits were manufactured.According to 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 dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.The operator uses procedures applicable to manufacture the devices according requirements.Quality auditor performs the inspection according aql and procedures.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 manufacturing site bd nogales.This failure mode is caused in the supplier process.

Event Description

It was reported that a anesthesia kit perisafe vi cal 18 arrived damaged.

• Brand Name: ANESTHESIA KIT PERISAFE VI CAL 18
• Type of Device: ANESTHESIA KIT
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8156597
• MDR Text Key: 130211024
• Report Number: 9610847-2018-00433
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 400722
• Device Lot Number: 8164995
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other