MAUDE Adverse Event Report: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR; ANESTHESIA KIT

Catalog Number 400866

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 25gx3.5in whit 5ml glaspak bupi clear was used and the anesthesia was ineffective.This was discovered during use.The following information was provided by the initial reporter: it was reported the bupivacaine was ineffective in this lot.

Event Description

It was reported that 25gx3.5in whit 5ml glaspak bupi clear was used and the anesthesia was ineffective.This was discovered during use.The following information was provided by the initial reporter: it was reported the bupivacaine was ineffective in this lot.

Manufacturer Narrative

H.6.Investigation: a review of the device history record noted no issues relating to the reported failure mode for 400866 lot # 0001343142.A sample was not returned for evaluation.However, retained samples were reviewed and confirmed as visually acceptable.The investigation was not able to identify or confirm any manufacturing contribution to the reported failure mode.All indicators suggest the product contained a drug with acceptable potency.Previous corrective actions, capa#67717 have already been implemented for ineffective anesthesia.H3 other text : see h.10.

Event Description

It was reported that 25gx3.5in whit 5ml glaspak bupi clear was used and the anesthesia was ineffective.This was discovered during use.The following information was provided by the initial reporter: it was reported the bupivacaine was ineffective in this lot.

Manufacturer Narrative

The following fields have been updated with corrections: site legal name (fda): becton dickinson - franklin lakes, nj / 07417.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.3.Medical device manufacturer: franklin lakes.D.4.Medical device expiration date: unknown.D.4.Medical device lot #: unknown.G.1.Manufacturing location: franklin lakes.H.4.Device manufacture date: unknown.

• Brand Name: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
• Type of Device: ANESTHESIA KIT
• MDR Report Key: 10090136
• MDR Text Key: 198296149
• Report Number: 1625685-2020-00047
• 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: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 400866
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• 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