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

Model Number	001187-77
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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).
Additional Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.- attachment: [complaint report for 285-18.Pdf].
Event or Problem 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
• Common Device Name: 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
• Report Number: 9611612-2018-00033
• Device Sequence Number: 1573373
• Product Code: BSP
• UDI-Device Identifier: 14048223020606
• UDI-Public: 14048223020606
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K111374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other