MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; LUMBAR PUNCTURE NEEDLE

Model Number 321151-31A

Device Problems Fitting Problem (2183); Device Issue (2379); Incorrect Device Or Component Shipped (2962); Mechanical Jam (2983)

Patient Problems Awareness during Anaesthesia (1707); No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary (b)(4).Neither the lot nor the exact date of event is known.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.

Event Description

(b)(4).Tentative summarizing translation of initial reporter's narrative: catheter does not fit well with needle.

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(6) distribution subsidiary (b)(4).File is considered as closed.No further action indicated, isolated event, human failure.

Event Description

Internal report-number: (b)(4).Tentative summarizing translation of initial reporter's narrative: unable to advance needle through introducer.

• Brand Name: SPROTTE
• Type of Device: 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; regulatory & safety affairs; geisingen, baden-wuerttemberg 78187 ; GM 78187 ; 7704929158
• MDR Report Key: 5659165
• MDR Text Key: 45656388
• Report Number: 9611612-2016-00064
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K911260
• 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: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/01/2021
• Device Model Number: 321151-31A
• Device Catalogue Number: 321151-31A
• Device Lot Number: 1145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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