MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE CATHETER ADAPTER; 868.5140 ANESTHESIA CONDUCTION KIT

Model Number BA110050

Device Problem Blocked Connection (2888)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2014

Event Type  malfunction  

Event Description

(b)(4).Event took place in (b)(6) and has not been reported to (b)(6).User's narrative from initial report: "adapter blocked, no passage for catheter.".

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 qual problems nor rejections related to this incident.If any further info is becoming available, mfr immediately will inform fda.If no further info is becoming available, mfr considers this file as closed.The failure arose in the manufacture of the clamping parts in the injection molding process.In the final test, the failure was not detected and thus not sorted out the defective product.Further deviations in the components, or the catheter could not be detected.The adapter has been tested with a new replacement clamping part and a purified catheter and then had a normal clamping force.The catheter was clamped properly, it could be injected without any problems.A systematic product failure cannot be confirmed.

• Brand Name: CATHETER ADAPTER
• Type of Device: 868.5140 ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-strasse 1; geisingen, baden-wurttemberg 7818 7; GM 78187
• Manufacturer Contact: christian quass, dir of reg affairs ; karl-hall-strasse 01; geisingen, baden-wurttemberg ; GM ; 7049291586
• MDR Report Key: 4016109
• MDR Text Key: 4844969
• Report Number: 9611612-2014-00009
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K082183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2018
• Device Model Number: BA110050
• Device Lot Number: 46213
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention