MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE; ANESTHESIA CONDUCTION KIT

Catalog Number 405672

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

Device expiration date: unknown.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the tray spn whit25g3.5 l/b-d/e blue drape caused a change in treatment/serious injury.The following information was provided by the initial reporter: material no.: 405672, batch: unknown.For patient 3/5.Per email: a patient was to undergo spinal anesthesia as primary anesthesia, but was still able to move their leg.Staff had to convert to general anesthesia.Similar results with multiple cases on the same day.

Manufacturer Narrative

Investigation: although a lot number was not provided for this particular complaint it is suspected that the lot number may be identical to a similar complaint since both complaints were reported at the same time by the same customer.A dhr review of all applicable manufacturing records for lot 0001275590 did not identify any issues that may have contributed to the reported failure mode.Although a complaint sample was not provided for this complaint it is suspected that the samples provided for a similar complaint are of particular significance (same suspected lot, same end user).The investigation could not confirm the failure mode for the samples provided for this other complaint.All thirteen (13) trays were opened and each bupivacaine vail was visually inspected for obvious defect.No defects were observed.Liquid within each vial was clear and without any visible particulate matter.The investigation was not able to identify or confirm any contribution to the reported failure mode from the factors noted above.Specific to the handling of the drugs, the investigation noted specific procedures to control the handling of any raw material drug component during the receipt, storage, and use in the manufacturing process.A review of the temperature monitoring system within the mannford facility did not identify any excursions that would have negatively affected any of the raw material drug components used within this product code.The investigation did identify this failure mode as a previously known issue.Based on the complaint investigation, a probable root cause could not be identified for the reported failure mode.The investigation identified a previous capa (capa 67717) performed by the bd anesthesia quality group that specifically investigated the ¿ineffective anesthesia¿ failure mode.Refer to capa 67717 for additional information regarding the outcome of the investigation.Likewise, the investigation identified a summary for previously investigated complaints (pic: (b)(4)) which provides rationale and information regarding the potential ineffective anesthesia outcome during the use of an anesthesia product code.Based on a review of all of these sources, the current complaint investigation could not identify a definitive root cause nor could any potential contributor be identified for this specific complaint failure mode.

Event Description

It was reported that the tray spn whit25g3.5 l/b-d/e blue drape caused a change in treatment/serious injury.The following information was provided by the initial reporter: material no.: 405672 batch: unknown.For patient 3/5.Per email: a patient was to undergo spinal anesthesia as primary anesthesia, but was still able to move their leg.Staff had to convert to general anesthesia.Similar results with multiple cases on the same day.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8595238
• MDR Text Key: 144720576
• Report Number: 1625685-2019-00028
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: 00382904056728
• Combination Product (y/n): N
• PMA/PMN Number: DISCRETION
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405672
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other