MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS - COLLECTEURS D'AIGUILLES; SHARPS CONTAINER

Catalog Number 305624

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

Patient Problem Exposure to Body Fluids (1745)

Event Date 07/06/2016

Event Type  Injury  

Manufacturer Narrative

Bd corporate headquarters in (b)(6) has been listed as carfi is an oem manufacturing site.There is no 510(k) for this device as it is manufactured outside the us and not sold in the us.It is unknown if a sample will be returned for evaluation.However, the customer provided photos of the device and they will be inspected as part of a no sample investigation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a caregiver stuck the palm of her hand with a used needle that perforated the lid of a bd sharps - collecteurs d'aiguilles as she was closing it.The caregiver confirmed the container was not full but it seems the sampling needle remained stuck vertically in the container."triple therapy treatment which consisted of 1 tablet of truvada, 1, 800 mg tablet of prezista, and 1 tablet of norvir during one month was provided to the caregiver.

Manufacturer Narrative

Results: a sample was not returned, however photos of the device were sent for evaluation.The photos clearly show a sharp is piercing through the top of the container.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6117001.Conclusion: although the photos confirmed the customer's indicated issue, without a sample an absolute root cause for this incident cannot be determined.Additionally, our quality engineer also states that the photos provided leads us to believe the sharps collector was over filled.Note the bd sharps collectors meet niosh guidelines for safe disposal.Container is not puncture proof but puncture resistant.

• Brand Name: BD¿ SHARPS - COLLECTEURS D'AIGUILLES
• Type of Device: SHARPS 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: 5837910
• MDR Text Key: 50907680
• Report Number: 2243072-2016-00019
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305624
• Device Lot Number: 6117001
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2016
• 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