MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; ANESTHESIA CONDUCTION KIT

Model Number 405637

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that tray spn spt24g3.5 l/b-d/e medication was not effective.This occurred on 22 occasions during use.The following information was provided by the initial reporter: material no.: 405637 batch no.: 0001330659.It was reported the bupivacaine is not effective.

Event Description

It was reported that tray spn spt24g3.5 l/b-d/e medication was not effective.This occurred on 22 occasions during use.The following information was provided by the initial reporter: material no.: 405637 batch no.: 0001330659.It was reported the bupivacaine is not effective.

Manufacturer Narrative

The following fields were updated due to additional information: d10.Device available for eval?: yes.D10.Returned to manufacturer on: 4/1/2020.H6.Investigation: a dhr review of all applicable manufacturing records for the lot did not identify any issues that may have contributed to the reported failure.A sample was returned for evaluation.The liquid was clear with no noticeable imperfections.The ampule was in good condition.The failure mode could not be confirmed through sample analysis.Each vial was visually inspected for obvious defect.No obvious defects were observed.Liquid within each vial was clear and without any visible particulate matter.Since no probable root cause was identified for this failure mode, the investigation was not able to identify any corrective actions for this complaint.Based on the reported failure mode, a supplier quality notification was sent to the vendor to notify them of the reported failure mode (ineffective anesthesia).

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9914316
• MDR Text Key: 198908907
• Report Number: 1625685-2020-00037
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056377
• UDI-Public: 00382904056377
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Model Number: 405637
• Device Catalogue Number: 405637
• Device Lot Number: 0001330659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2019
• 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