MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE FUSER PUMP SET; 868.5120 ANESTHESIA CONDUCTION CATHETER

Model Number 001157-10A

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 12/01/2013

Event Type  Other  

Event Description

(b)(4).Event took place in (b)(6) and has not been reported to (b)(6) health authorities.Summarizing tentative translation: catheter placement after total knee arthroplasty was performed intra-articularly.Catheter ripped when pulling about to skin level, a piece remained in the knee and had to be level, a piece remained in the knee and had to be removed arthroscopically, the x-ray showed that the catheter had wound up in the joint.The lot could not be called.The claimed sample was not available.

Manufacturer Narrative

No specific corrective action due to mitigative prevention of hazards is assigned to this report.A review of the relevant device history records and the raw material history files did neither indicate recorded quality problems nor rejections related to this incident.If any further information is becoming available, mfr immediately will inform fda.If no further information is becoming available, mfr considers this file as closed.

• Brand Name: FUSER PUMP SET
• Type of Device: 868.5120 ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-strasse 01; geisingen, baden-wurttemberg 7818 7; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187 ; 7704929158
• MDR Report Key: 3772390
• MDR Text Key: 4373664
• Report Number: 9611612-2014-00001
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K080675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Type of Report: Initial
• Report Date: 02/27/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: 001157-10A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2013
• Initial Date FDA Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention