MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR

Model Number 306547

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 5 bd¿ sharps collectors were missing their lid clamps.The following information was provided by the initial reporter: "1ca (5ea) do not have the sliders to close the lid".

Event Description

It was reported that 5 bd¿ sharps collectors were missing their lid clamps.The following information was provided by the initial reporter: "1ca (5ea) do not have the sliders to close the lid".

Manufacturer Narrative

H.6.Investigation: no photo or sample was received with the customer's complaint of missing slide clamp.Without further evidence like a physical sample or photos of the reported failure, the complaint cannot be verified and the root cause remains unknown.According to the dhr review process; the result showed there were no issues reported like missing slider during the manufacturing process of the lot number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like missing slider for the same part number throughout the last twelve months.H3 other text : see h.10.

• Brand Name: BD¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13040975
• MDR Text Key: 285806276
• Report Number: 2243072-2021-02939
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K003553
• 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
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 306547
• Device Catalogue Number: 305647
• Device Lot Number: 1200917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• 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