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

Model Number	305488
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd¿ multiuse one-piece sharps collector hinge cap with petals the lid did not close properly.This occurred 48 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: according to the customer's report, the lid does not shut.
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.D.4.Medical device expiration date: na.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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 7 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 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.A device history record review showed no non-conformances associated with this issue during the production of this batch.Corrective and/preventive action: implement automatic cap press into production: an air actuated press has been implemented to assist operators with the assembly of the cap to the bottles on the manufacturing floor.This action took place in late 2022.H3 other text : see h10.
Event or Problem Description
It was reported while using bd¿ multi-use one-piece sharps collector hinge cap with petals the lid did not close properly.This occurred 48 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: according to the customer's report, the lid does not shut.

• Brand Name: BD¿ MULTIUSE ONE-PIECE SHARPS COLLECTOR HINGE CAP WITH PETALS
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 16843590
• Report Number: 2243072-2023-00677
• Device Sequence Number: 17857676
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/18/2023
• 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