MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX PENCIL POINT SPINAL NEEDLE SET; NEEDLE, SPINAL, SHORT TERM

Catalog Number 100/496/125

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

Report source: foreign country: (b)(6).

Event Description

Information was received that the needle and introducer within a smiths medical portex pencil point spinal needle set were inspected prior to insertion without issue.Subsequently, the needle was inserted into a patient's lower back.Upon slow withdrawal of the needle during removal, the reporter stated there was a sudden loss of resistance felt and only half of needle came out of the patient, while the other half broke off inside the patient's back.It was also reported that it was required for a neurologist to surgically remove the remaining needle and the patient's operation was performed as scheduled.No additional adverse patient effects were reported.

• Brand Name: PORTEX PENCIL POINT SPINAL NEEDLE SET
• 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 NORTH AMERICA; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9221513
• MDR Text Key: 164343139
• Report Number: 3012307300-2019-05616
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2024
• Device Catalogue Number: 100/496/125
• Device Lot Number: 3815903
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2019
• 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