MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPINAL NEEDLE; ANAESTHESIA CONDUCTION NEEDLE SINGLE SHOT, SPINAL

Model Number UNKNOWN

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.In original condition the needle has been supplied in bulk, non sterile status to a kit packager.Currently due to lack of information we are unable to confirm the item number, brand name and lot of the needle.

Event Description

(b)(4).Initial reporter´s narrative: non-sterile sample of spinal needle (?) which has been unambiguously labelled as such has been used with patient.

Manufacturer Narrative

Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.In original condition the needle has been supplied in bulk, non sterile status to a kit packager.Currently due to lack of information we are unable to confirm the item number, brand name and lot of the needle.Based on risk assessment and clinical assessment file is considered as closed.

Event Description

Irn#: (b)(4).Initial reporter´s narrative: non-sterile sample of spinal needle (?) which has been unambiguously labelled as such has been used with patient.

• Brand Name: SPINAL NEEDLE
• Type of Device: ANAESTHESIA CONDUCTION NEEDLE SINGLE SHOT, SPINAL
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 8783551
• MDR Text Key: 150852776
• Report Number: 9611612-2019-00020
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: BNS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other