MAUDE Adverse Event Report: BD BD MULTI-USE ONE-PIECE SHARPS COLLECTOR

Catalog Number 305490

Device Problem Use of Device Problem (1670)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Type  Injury  

Event Description

Two needles were protruding following the autoclaving of the sharps container.Two employees, one a lab staff member and one a custodial worker, sustained needlestick injuries when handling the container.The custodial staff member was disposing of the container in the dumpster when the needlestick occurred.The lab staff member who was investigating the first needlestick also got stuck.It is unk if the custodial worker received any treatment as he/she is contracted personnel and not hospital staff.The lab staff member followed standard protocol of having labs drawn.No further info is available.

Manufacturer Narrative

The sample is not available for eval and a root cause for these incidents could not be identified.A review of the device history records revealed no irregularities during the manufacture of reported lot number 2331001.

• Brand Name: BD MULTI-USE ONE-PIECE SHARPS COLLECTOR
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BD; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer (Section G): PREMIUM PLASTIC SOLUTION; 59 bay hill drive; latrobe PA 15650
• Manufacturer Contact: brett wilko ; 1 becton dr.; franklin lakes, NJ 07417 ; 8015652341
• MDR Report Key: 3787021
• MDR Text Key: 4432947
• Report Number: 2243072-2014-00065
• Device Sequence Number: 1
• Product Code: MMK
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 305490
• Device Lot Number: 2331001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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 Outcome(s): Required Intervention