MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STANDARD SPROTTE; ANAETHESIA CONDUCTION NEEDLE

Model Number 021151-29A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Event Description

Irn#: (b)(4).Tentative translation of initial reporter´s narrative: cannula breakage during spinal anaesthesia.

• Brand Name: STANDARD SPROTTE
• Type of Device: ANAETHESIA CONDUCTION 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: 10315599
• MDR Text Key: 242439230
• Report Number: 9611612-2020-00005
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223000257
• UDI-Public: 14048223000257
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/23/2020

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 Model Number: 021151-29A
• Device Catalogue Number: 021151-29A
• Device Lot Number: 1321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2019
• 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