MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG SONO; PERIPHERAL NERVE BLOCK KIT

Model Number 531157-32A

Device Problems Crack (1135); Fluid/Blood Leak (1250); Chemical Problem (2893); Device Handling Problem (3265)

Patient Problems Awareness during Anaesthesia (1707); Inadequate Pain Relief (2388)

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6), actual date of the event is unknown.As soon as further information becomes available and as soon as the investigations have been finished a follow up report will be sent.

Event Description

(b)(4).Tentative summarizing translation from user's narrative: when connecting the filter to the infusion line it cracked.Had to be replaced.

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed.

Event Description

(b)(4).Date of event still unknown.Tentative summarizing translation from user's narrative: when connecting the filter to the infusion line it cracked.Had to be replaced.Two (2) filters involved.

• Brand Name: STIMULONG SONO
• Type of Device: PERIPHERAL NERVE BLOCK KIT
• 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: 5549874
• MDR Text Key: 41956717
• Report Number: 9611612-2016-00041
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113188
• 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: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/01/2020
• Device Model Number: 531157-32A
• Device Catalogue Number: 531157-32A
• Device Lot Number: 1139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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