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

Catalog Number 5460-ZKP

Device Problem Break (1069)

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

Event Date 03/31/2023

Event Type  malfunction  

Event Description

It was reported that the bd¿ sharps collector lid would not stay securely closed.The following information was provided by the initial reporter: "we have recently received feedback from our ground that 5460-zkp (with round cap and red label) is unable to close tight after use.During disposal, the cap tends to pop open as it does not securely close.This is posing a hazard to our housekeeping staff.Our nursing colleagues have been taping down the cap with scotch tape, which should not be the case.".

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is schenker.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.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 the bd¿ sharps collector lid would not stay securely closed.The following information was provided by the initial reporter: "we have recently received feedback from our ground that 5460-zkp (with round cap and red label) is unable to close tight after use.During disposal, the cap tends to pop open as it does not securely close.This is posing a hazard to our housekeeping staff.Our nursing colleagues have been taping down the cap with scotch tape, which should not be the case.".

Manufacturer Narrative

H6: investigation summary no sample or photos received.No defective sample or photos and no additional information was available.According to the dhr review process, the result showed there were no issues reported like lid will not shut during the manufacturing process.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid will not shut for the same part number throughout the last twelve months.

• 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: 16773636
• MDR Text Key: 313828423
• Report Number: 2243072-2023-00651
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 06/12/2023

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: Health Professional
• Device Catalogue Number: 5460-ZKP
• Device Lot Number: 2F801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2012
• 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