MAUDE Adverse Event Report: SYNTHES (USA) NITROGEN REGULATOR-COMPLETE WITH COUPLERS

Catalog Number 520.89

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: the nitrogen regulator safety valve was leaky post-surgical procedure.No harm was reported.This is report 1 of 1 for this event (b)(4).

Manufacturer Narrative

Additional common device name hwe.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(6).Placeholder.

Manufacturer Narrative

(b)(4): the inspection of the device revealed the device was received with a leaky valve.The reported observation is due to normal wear of the device.The device was repaired and returned to the customer on 02april2014.The service history review was not available.(b)(4).

• Brand Name: NITROGEN REGULATOR-COMPLETE WITH COUPLERS
• Manufacturer (Section D): SYNTHES (USA); west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3640432
• MDR Text Key: 4283500
• Report Number: 2520274-2014-00770
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K971544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 520.89
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 02/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1