MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX SPINAL ANESTHESIA KIT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	01/12/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
User facility reported that the device was placed in use with patient for spinal anesthesia but the drug did not take effect.According to reporter, the procedure required general anesthesia due to this issue.No permanent adverse effects to patient reported.
Additional Manufacturer Narrative
Twenty original sealed trays and (b)(4) original cases of product were returned for investigation.Ten samples were forwarded to the supplier of the anaesthesia medication for evaluation.The supplier performed visual examinations on the product and reported that they could not find any issues with the samples.The supplier preformed a complete review of their manufacturing records for the reported lot associated with the reported product issue.The supplier concluded that the bupivacaine 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.Smiths medical forwarded (b)(4) of the samples to their accredited laboratory for potency testing.Potency testing was found within specification (b)(4) for all tested samples.Testing customer's returned samples and evaluating retain samples could not duplicate the reported product issue.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.No corrective actions are planned at this time.

• Brand Name: PORTEX SPINAL ANESTHESIA KIT
• Common Device Name: PORTEX SPINAL ANESTHESIA KIT
• Manufacturer (Section D): SMITHS MEDICAL; 10 bowman dr.; keene NH 03431
• MDR Report Key: 5449198
• Report Number: 2183502-2016-00267
• Device Sequence Number: 16249675
• Product Code: CAZ
• UDI-Device Identifier: 30351688069287
• UDI-Public: 30351688069287
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2016

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?: No
• Operator of Device: Other
• Device Expiration Date: 03/31/2017
• Device Model Number: N/A
• Device Catalogue Number: A3391-25
• Device Lot Number: 3065998
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2016
• Supplement Report FDA Received Date: 04/12/2016
• 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