MAUDE Adverse Event Report: BECTON DICKINSON 22.7 L BD¿ NESTABLE SHARPS COLLECTOR

Catalog Number 300483

Device Problem Material Integrity Problem (2978)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma / 510(k) #: there is no 510(k) # for this device as it is marketed outside the us.A sample is not available, however the customer has provided photos of the device in question.A photo evaluation and device history record review will be completed as part of a no sample investigation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a needle pierced through a 22.7 l bd" nestable sharps collector and an employee was stuck with a contaminated needle from an unknown source patient.The needle stick injury occurred after the employee had picked up the container from an autoclave.The employee received post exposure lab work and the test results were negative.

Manufacturer Narrative

Results: a sample is not available for evaluation, however the customer provided photos of the device in question.A photo inspection revealed that a needle had penetrated the wall of the sharps collector.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5261930.Conclusion: although the photos confirmed the customer's indicated failure mode, without a sample, an absolute root cause for this incident cannot be determined as the device history record indicates that the product meets all attribute and variable characteristics.

• Brand Name: 22.7 L BD¿ NESTABLE SHARPS COLLECTOR
• Type of Device: SHARPS COLLECTOR
• 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: 6103865
• MDR Text Key: 59974520
• Report Number: 2243072-2016-00041
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• 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,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300483
• Device Lot Number: 5261930
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention