MAUDE Adverse Event Report: CAREFUSION, INC 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE; ANESTHESIA CONDUCTION KIT

Catalog Number	405672
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The reported lot# 001273494 was not found for the catalog number.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Dhr could not be performed as the lot# given is not a valid lot#.
Event or Problem Description
It was reported that a drug potency issue occurred with a tray spn whit25g3.5 l/b-d/e blue drape.The following information was provided by the initial reporter, "it was brought to my attention that anesthesia is having trouble with the bupivacaine not working in the spinal trays ref: 405672, lot # 001273494, exp: 2020-09-30.They have been pulling bupivacaine from the pyxis since they have had so many failed spinals from this lot.".

• Brand Name: 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 9145020
• Report Number: 1625685-2019-00117
• Device Sequence Number: 16631935
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: 00382904056728
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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 Catalogue Number: 405672
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other