MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS; LUMBAR PUNCTURE TRAY 20GX3.5"

Catalog Number DYNJTS4301

Device Problem Material Integrity Problem (2978)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/01/2023

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer contact that in (b)(6) 2023, "clinician was placing the needle back into the cap, he picked up the capped needle and syringe.He then went to double lock the cap onto the syringe when puncture occurred via needle piercing defective plastic security cap".It was reported that due to this, "he was treated with medication and blood draws.He was advise weekly follow-up and advise to stop other medications".A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

"needle piercing defective plastic security cap" after recapping used needle.

• Type of Device: LUMBAR PUNCTURE TRAY 20GX3.5"
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 3310 s main st; salisbury NC 28147
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18707674
• MDR Text Key: 335403507
• Report Number: 1038445-2024-00001
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2024

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 Catalogue Number: DYNJTS4301
• Device Lot Number: 2022041350
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other