MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG CURL SONO; PERIPHERAL ANAESTHESIA CONDUCTION CATHETER

Model Number 521188-34C

Device Problem Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(4).From initial reporter: (b)(6) clinic was given to a patient rectus sheet block on both sides after a gynecological surgery for pain management on (b)(6) 2017 with pajunk sonolong curl echo catheters purchased from mediq (b)(4).The procedure went smoothly.On (b)(6) 2017 catheters were removed from the upper abdomen.The nurse removed the second catheter without any problems, but in another catheter there seemed to be a resistance.When pulling the catheter, it really felt a resistance and mild pain in the upper abdomen, and pulling the catheter continued until the white catheter came out of the skin.From the inside of the catheter appeared a frustrated metal wire-like line that stretched and stretched until it broke.There was apparently the catheter's head in the patient because the black point on the tip was missing from the out coming catheter.There was also left an unknown number of steel helical coil in the patient.It was suspected that the catheter's head would have gone into node because the injection site was such that the catheter would not be able to stick to any structure.

• Brand Name: SONOLONG CURL SONO
• Type of Device: PERIPHERAL ANAESTHESIA CONDUCTION CATHETER
• 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; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7163625
• MDR Text Key: 96341034
• Report Number: 9611612-2018-00005
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 14048223020385
• UDI-Public: 14048223020385
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K113188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 521188-34C
• Device Catalogue Number: 521188-34C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention