MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOPLEX; PERIPHERAL NERVE BLOCK NEEDLES

Model Number 001187-77

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

Currently, the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.

Event Description

(b)(4).We have received 2 boxes or more of defective needles.They are leaking before use.It is only product # 001187-77 and lot #1251 purchased on (b)(4).All other lot #'s seem to be okay however we still need to file a report and get more needles in.As previously stated i have 2 defective boxes on my desk (one box is open).Can i be credited these? i placed an order for 2 new boxes on (b)(4).

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed.- attachment: [complaint report for 285-18.Pdf].

Event Description

Irn# 576_285-18 we have received 2 boxes or more of defective needles.They are leaking before use.It is only product #001187-77 and lot #1251 purchased on po mm76187.All other lot #'s seem to be okay however we still need to file a report and get more needles in.As previously stated i have 2 defective boxes on my desk (one box is open).Can i be credited these? i placed an order for 2 new boxes on mm77050.

• Brand Name: SONOPLEX
• Type of Device: PERIPHERAL NERVE BLOCK NEEDLES
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7808033
• MDR Text Key: 118094000
• Report Number: 9611612-2018-00033
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223020606
• UDI-Public: 14048223020606
• Combination Product (y/n): N
• PMA/PMN Number: K111374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2021
• Device Model Number: 001187-77
• Device Catalogue Number: 001187-77
• Device Lot Number: 1251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Date Manufacturer Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other