MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE 2.G; SPINAL ANAESTHESIA/ LUMBAR PUNCTURE NEEDLE

Model Number 141251-27A

Device Problems Break (1069); Crack (1135); Fluid/Blood Leak (1250); Leak/Splash (1354); Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Inadequate Pain Relief (2388); No Information (3190)

Event Date 10/06/2017

Event Type  malfunction  

Event Description

(b)(4).From initial reporters narrative: leakage at the hub.

Manufacturer Narrative

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

Event Description

(b)(4).From initial reporters narrative: leakage at the hub.

• Brand Name: SPROTTE 2.G
• Type of Device: SPINAL ANAESTHESIA/ LUMBAR PUNCTURE NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7005453
• MDR Text Key: 92488995
• Report Number: 9611612-2017-00012
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223022815
• UDI-Public: 14048223022815
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/27/2022
• Device Model Number: 141251-27A
• Device Catalogue Number: 141251-27A
• Device Lot Number: 1199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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