MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE 2G; ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT

Model Number 121251-27A

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4) distributor (b)(4).Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent into the agency.

Event Description

(b)(4).Initial reporter´s narrative: the needles broke when the doctor was using it on a patient, they could take out the needle from the patient's back without any harm to the patient.

Event Description

(b)(4).Initial reporter´s narrative: the needles broke when the doctor was using it on a patient, they could take out the needle from the patients back without any harm to the patient.

Manufacturer Narrative

Event took place in sweden and has been reported through swedish distributor mediq.Based on risk assessment and clinical evaluation file is considered as closed.

• Brand Name: SPROTTE 2G
• Type of Device: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 8761730
• MDR Text Key: 150134438
• Report Number: 9611612-2019-00018
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223022808
• UDI-Public: 14048223022808
• Combination Product (y/n): N
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: 121251-27A
• Device Catalogue Number: 121251-27A
• Device Lot Number: 1264
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/04/2019
• Supplement Dates Manufacturer Received: 07/01/2019
• Supplement Dates FDA Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other