MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SPINAL KIT; ANESTHESIA CONDUCTION KIT

Catalog Number	A3571-27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the investigation site.
Event or Problem Description
It was reported that the needle of a portex® spinal kit broke off in the patient, and a portion of the needle was left in the patient.It was noted that the needle broke off 3cm from the hub during insertion when hitting the vertebrae.The fragment was removed.No permanent injury was reported.
Additional Manufacturer Narrative
A review of the device history record was performed, and no discrepancies were found.One used spinal needle stylet and two spinal needle fragments were received for analysis.One fragment of the spinal needle was straight, attached to the hub, and measured approximately 4.7 mm.The second fragment of the spinal needle was bent and measured approximately 3.7 mm.The physical characteristics of the fragments as well as evaluation of the both ends of the affected area suggested that the reported issue was most likely consistent with breakage.The breakage could have possibly occurred as a result of impact from obstruction either inside the patient or inside the introducer needle; the breakage may have also resulted from insertion or removal technique, resulting in interaction between spinal and introducer needle.Specific details that would indicate clinician technique during positioning or removal the needles are not available as of this time.Without the return of the actual introducer needle, a definitive root cause to the clinical observation could not be determined.

• Brand Name: PORTEX® SPINAL KIT
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6718458
• Report Number: 3012307300-2017-01504
• Device Sequence Number: 19082334
• Product Code: CAZ
• UDI-Device Identifier: 20351688072778
• UDI-Public: 20351688072778
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

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: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: A3571-27
• Device Lot Number: 3266189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 09/20/2017
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 109