MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; SPINAL NEEDLE, SINGLE USE

Model Number 511151-29A

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2021

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6).Based on available data, risk assessment and clinical evaluation report this file is considered as closed.

Event Description

Irn# (b)(4).Tentative summarizing translation from initial reporter´s narrative: "hub of intorducer came off during removal.".

• Brand Name: SPROTTE
• Type of Device: SPINAL NEEDLE, SINGLE USE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 12030753
• MDR Text Key: 260735684
• Report Number: 9611612-2021-00008
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 04048223066898
• UDI-Public: 04048223066898
• Combination Product (y/n): N
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 511151-29A
• Device Catalogue Number: 511151-29A
• Device Lot Number: 1378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Date Manufacturer Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2020
• 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