MAUDE Adverse Event Report: BECTON DICKINSON BD ECLIPSE¿ COMPATIBLE DISPOSAL CONTAINER; NEEDLE DISPOSAL CONTAINER

Catalog Number 367216

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

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).There is no 510(k) # for this device as it is marketed outside the us.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a nurse discovered that a bd eclipse compatible disposal container was full and its contents needed to be disposed of.As she went to close the cover she was stuck on her left index finger by a contaminated needle that had punctured the wall of the container.The needles in the container had been used for subcutaneous injections.The nurse followed her facility's "blood contact protocol." it is unknown what the specifics of the blood contact protocol are or if any other medical interventions were provided.

Manufacturer Narrative

Results: although it was initially reported that a device would be returned for evaluation, the device was not sent.A photo of the device was evaluated and showed the location of the reported puncture through the wall of the sharps collector.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5222901.(b)(4).

• Brand Name: BD ECLIPSE¿ COMPATIBLE DISPOSAL CONTAINER
• Type of Device: NEEDLE DISPOSAL CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5530426
• MDR Text Key: 41310117
• Report Number: 2243072-2016-00003
• Device Sequence Number: 0
• Product Code: MMK
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 367216
• Device Lot Number: 5222901
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention