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

Model Number 021251-29A

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Based on risk management evaluation and clinical evaluation this file is considered as closed.

Event Description

(b)(4).Tentative translation, summarizing, from initial reporter´s narrative: cannula is broken off at the transparent hub.Cannula still protruded 2 mm out of patient's back.The cannula could be pulled out of the patient with a sterile clamp.Patient lay in lateral position.

• Brand Name: SPROTTE 2.G
• Type of Device: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7976641
• MDR Text Key: 124065452
• Report Number: 9611612-2018-00039
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223024307
• UDI-Public: 14048223024307
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2018

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: 09/04/2022
• Device Model Number: 021251-29A
• Device Catalogue Number: 021251-29A
• Device Lot Number: 1219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2017
• 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