MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; SPINAL NEEDLE

Model Number	121151-27A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on risk assessment and clinical assessment file is considered as closed.
Event or Problem Description
Irn#: (b)(4).Spinal anaesthesia was used during c-section.Upon removal, staff noticed that the needle is short, a part of the needle remained inside the patient.Patient was transported to another institution, put under x-ray.The needle was stuck in fat tissue outside of vertebrae.It needed to be removed surgically via incision.A follow-up x-ray determined that the patient was metal-free, the scar tissue was in the process of healing without complications.Patient was discharged to her home on july 14th.In addition to the referenced affected quantity of 38 below, there were several needles that had been bent or deformed as reported by the customer.

• Brand Name: SPROTTE
• Common Device Name: SPINAL NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 10369801
• Report Number: 9611612-2020-00008
• Device Sequence Number: 2408966
• Product Code: BSP
• UDI-Device Identifier: 14048223001438
• UDI-Public: 14048223001438
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: 121151-27A
• Device Catalogue Number: 121151-27A
• Device Lot Number: 1296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/05/2020
• 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: Other