MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PENCIL POINT SPINAL NEEDLE SETS (WHITACRE); NEEDLE, SPINAL, SHORT TERM

Catalog Number 100/496/127

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.(b)(4).

Event Description

It was reported that the tip of the spinal needle broke and remained in the patient's body between the l4 and l5 vetebrae.Surgery was performed on the following day to remove the needle tip.In addition the patient was also given three tablets of ibuprofen 600mg.No permanent adverse effects to the patient were reported.

Manufacturer Narrative

One 27 gauge 90mm spinal pencil (part number: 005/000/060) was received for investigation.Visual inspection of the returned sample found that approximately 38mm of the needle had been returned, the needle was measured from the tip to the breakage point.It was observed that the needle was bent approximately 29mm from the tip of the needle.As no finished good lot number was provided for the complaint a supplier investigation could not be conducted and no root cause could be determined.

• Brand Name: PENCIL POINT SPINAL NEEDLE SETS (WHITACRE)
• 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: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6210964
• MDR Text Key: 63470857
• Report Number: 3012307300-2016-00653
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 100/496/127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Weight: 107