MAUDE Adverse Event Report: MANSFIELD MANUFACTURING SITE ELITE PASS NEEDLES; TRUEPASS NEEDLE,SINGLE PACK

Model Number 72203793

Device Problem Material Fragmentation (1261)

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

Event Date 06/09/2014

Event Type  malfunction  

Event Description

The surgeon inserted the needle thru the cuff and the tip broke off.The surgeon did the case open and therefore couldn't really tell the thickness of the cuff.The bite was not very aggressive.The surgeon said the pass was under direct vision.The second pass was really hard to pass and he had to force the instrument to pass the needle.It was noticed that the needle was broken after the third pass.The surgeon said there was no bone where he was passing the needle.X-ray was taken and no metal pieces were found.Back-up device was available.No patient injury or complications took place.

Manufacturer Narrative

Customer indicates that no product will be returned for analysis.(b)(4).

• Brand Name: ELITE PASS NEEDLES
• Type of Device: TRUEPASS NEEDLE,SINGLE PACK
• Manufacturer (Section D): MANSFIELD MANUFACTURING SITE; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): MANSFIELD MANUFACTURING SITE; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: robert bombard ; 150 minuteman road; andover, MA 01810 ; 9787491561
• MDR Report Key: 3913968
• MDR Text Key: 17990051
• Report Number: 1219602-2014-00194
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: 72203793
• Device Catalogue Number: 72203793
• Device Lot Number: 50491214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/09/2014
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/10/2014
• Date Device Manufactured: 01/29/2014
• 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