MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR; SHARPS CONTAINER

Catalog Number 303208

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that a needle pierced through the wall of the bd¿ sharps collector and caused a dirty needle stick injury to the staff member.The following information was provided by the initial reporter: "needle pierced sharps collector causing needle stick injury to staff member through routine use.".

Event Description

It was reported that a needle pierced through the wall of the bd¿ sharps collector and caused a dirty needle stick injury to the staff member.The following information was provided by the initial reporter: "needle pierced sharps collector causing needle stick injury to staff member through routine use".

Manufacturer Narrative

H6: investigation summary no sample was provided for investigation by the customer.Photos are provided for verification and needle pierced sharps collector causing needle stick issue was verified.A device history record review could not be performed because a lot number was not provided by the customer.Investigation and root cause: without the actual affected sample for evidence and investigation the actual root cause could not be verified however the most reasonable explanation is that the collector container has been overfilled (instructions not followed for filling of container) and dropped.This causing the needle to penetrate the collector container.No corrective action needed.H3 other text : see h10.

• Brand Name: BD¿ SHARPS COLLECTOR
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16989495
• MDR Text Key: 315825307
• Report Number: 2243072-2023-00867
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303208
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention