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

Model Number 321151-31A

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371); Misassembly by Users (3133); Device Handling Problem (3265)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6).At this point of time no further data is available.A follow up will be sent as soon as further information becomes available.Not sent back.

Event Description

(b)(4).Users narrative: retaining plate got loosened, unable to navigate needle.

Manufacturer Narrative

If no further information becomes available, this file is considered to be closed.

Event Description

Internal report number: (b)(4).User's narrative tentative translation: retaining plate got loosened, difficult to navigate.Update: event took place in week 2 of (b)(6) 2016.

• Brand Name: SPROTTE
• Type of Device: DIAGNOSTIC 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: 5446645
• MDR Text Key: 39126125
• Report Number: 9611612-2016-00012
• 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: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/01/2019
• Device Model Number: 321151-31A
• Device Catalogue Number: 321151-31A
• Device Lot Number: 1063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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