MAUDE Adverse Event Report: BECTON DICKINSON BD¿ MULTIUSE ONE-PIECE SHARPS COLLECTOR HINGE CAP; HYPODERMIC SINGLE LUMEN NEEDLEFMI

Model Number	305488
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is pps.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.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd¿ multiuse one-piece sharps collector hinge cap the lid was damaged.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about broken lids of sharps collector.The customer reported that lids were found to be detached.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 26-apr-2023 h6: investigation summary 2 samples and photos were returned by the customer.According to the customer's report, the lid does not shut was verified.The investigation performed on basis of photo and sample representation.Requirement(s): the lids should be properly installed while bottles are molded (hot) so that the lids snap onto the containers and remain snapped in place permanently.Investigation: proper installation of the caps require the bottles & caps to be warm (right after molding) and require significant force to secure the cap completely to the bottle.This was being done manually throughout 2022 and prior.Due to the high physical requirements needed, some operators may not have had the strength necessary to complete this task efficiently.This was recognized and an automatic cap press was built in late 2022 to alleviate the issue.See h10.
Event or Problem Description
It was reported while using bd¿ multiuse one-piece sharps collector hinge cap the lid was damaged.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about broken lids of sharps collector.The customer reported that lids were found to be detached.

• Brand Name: BD¿ MULTIUSE ONE-PIECE SHARPS COLLECTOR HINGE CAP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLEFMI
• 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: 16873315
• Report Number: 2243072-2023-00742
• Device Sequence Number: 12578324
• Product Code: FMI
• UDI-Device Identifier: 00382903054886
• UDI-Public: (01)00382903054886
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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
• Operator of Device: Other
• Device Model Number: 305488
• Device Catalogue Number: 305488
• Device Lot Number: 2053002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown