MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® SPINAL NEEDLE SETS; NEEDLE, SPINAL, SHORT TERM

Catalog Number 100/496/122

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2017

Event Type  Injury  

Event Description

It was reported that during a lumbar puncture the hub of a portex®spinal needle detached from the needle itself, leaving the latter in the patient's back.Following needle removal, a second lumbar puncture was required.The needle was removed with forceps.There was no other associated injury.

Manufacturer Narrative

One used needle was received for investigation.Through visual inspection it was confirmed that the needle had become detached from the needle hub.The supplier performed additional investigation on the device but could not identify a root cause for the needle detachment.The supplier did note the possibility of detaching the needle from the hub with use of excessive force.

• Brand Name: PORTEX® SPINAL NEEDLE SETS
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; 52 grayshill road; cumbernauld, glasgow G68 9 HQ; UK G68 9HQ
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7084167
• MDR Text Key: 93764464
• Report Number: 3012307300-2017-02504
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 100/496/122
• Device Lot Number: 3436028
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2017
• 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): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 130