MAUDE Adverse Event Report: MANSFIELD MANUFACTURING SITE ACCU-PASS; ACCU-PASS STR SHUTTLE STRAIGHT

Model Number 7210426

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/09/2014

Event Type  Injury  

Event Description

It was reported that the device was used on a patient during surgery.The nurse used this item then placed it on her mayo stand.She then reached over the mayo stand and the item punctured her arm through her gown.The nurse followed-up with occupational health per hospital protocol.No information in regards to any type of treatment of the puncture wound is available at this time.

Manufacturer Narrative

No product will be returned for evaluation.(b)(4).

• Brand Name: ACCU-PASS
• Type of Device: ACCU-PASS STR SHUTTLE STRAIGHT
• 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: 4010756
• MDR Text Key: 4690001
• Report Number: 1219602-2014-00245
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2014

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 Expiration Date: 12/31/2016
• Device Model Number: 7210426
• Device Catalogue Number: 7210426
• Device Lot Number: 50490075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/09/2014
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/23/2014
• Initial Date FDA Received: 08/14/2014
• Date Device Manufactured: 01/21/2014
• 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
• Patient Age: 45 YR