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

Model Number	405637
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9914316
• Report Number: 1625685-2020-00037
• Device Sequence Number: 11581281
• Product Code: CAZ
• UDI-Device Identifier: 00382904056377
• UDI-Public: 00382904056377
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 07/17/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other