MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG SONO; PERIPHERAL NERVE BLOCK KIT/ CATHETER

Model Number 521187-31A

Device Problems Material Separation (1562); Sticking (1597)

Patient Problems No Consequences Or Impact To Patient (2199); Anxiety (2328)

Event Date 02/04/2016

Event Type  malfunction  

Event Description

Internal identifier: (b)(4).Event took place in (b)(6) and has been reported to (b)(4) health authority (b)(4) by user tentative summarizing translation from (b)(4) user's narrative: upon removal of the catheter the inner coil of the catheter "stuck" (the polyamide catheter was removed over the coil, but the stainless steel coil hang in tissue).By carefully removing the coil afterwards breakage or fragmentation could be avoided.The intervention was delayed, but there was no actual harm to the patient.Patient is afraid of material remaining inside his body.

Event Description

(b)(4).Event took place in (b)(6) and has been reported to german health authority bfarm by user tentative summarizing translation from (b)(6) user's narrative: upon removal of the catheter, the inner coil of the catheter "stuck" (the polyamide catheter was removed over the coil, but the stainless steel coil hang in tissue).By carefully removing the coil afterwards breakage or fragmentation could be avoided.The intervention was delayed, but there was no actual harm to the patient.Patient is afraid of material remaining inside his body.

• Brand Name: SONOLONG SONO
• Type of Device: PERIPHERAL NERVE BLOCK KIT/ 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; regulatory & safety affairs; geisingen, baden-wuerttemberg 78187 ; GM 78187 ; 7704929158
• MDR Report Key: 5429812
• MDR Text Key: 38041208
• Report Number: 9611612-2016-00002
• Device Sequence Number: 1
• Product Code: BSO
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 521187-31A
• Device Catalogue Number: 521187-31A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2016
• 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): Required Intervention
• Patient Age: 37 YR