MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX SPINAL ANESTHESIA TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number A3939-25

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

Patient Problem Awareness during Anaesthesia (1707)

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a patient received insufficient local anesthesia when the listed medical device was used.It was necessary to place patient under general anesthesia during the procedure.No adverse effects to patient reported.

Manufacturer Narrative

Correction report being sent to include lot number provided by reporter following submission if initial mdr.Investigation is currently in process.Once results available, an additional follow-up will be submitted including those results of evaluation.

Manufacturer Narrative

Field samples were not returned for evaluation.The supplier of the anaesthesia medication preformed a complete review of their manufacturing records for all marcaine-bupivacaine lots that could be associated with the reported product issue.The supplier concluded that all marcaine-bupivacaine product met specifications at final testing.The supplier also tested retained samples for potency.All testing found the product to meet specifications with no degradation or loss of efficacy.As the reported product issue could not be confirmed through testing, an exact root cause could not be determined.Possible cause for the lack of effect may be related to administration technique or patient anatomical variations, including pathological or psychological factors.

• Brand Name: PORTEX SPINAL ANESTHESIA TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL; 10 bowman drive; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5177748
• MDR Text Key: 29241509
• Report Number: 2183502-2015-00799
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: A3939-25
• Device Lot Number: 3016492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other