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

Model Number 121151-27A

Device Problem Break (1069)

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

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

Based on risk assessment and clinical assessment file is considered as closed.

Event 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
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 10369801
• MDR Text Key: 233892000
• Report Number: 9611612-2020-00008
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223001438
• UDI-Public: 14048223001438
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2019
• 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): Other