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	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Additional 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 device expiration date: na.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd¿ multiuse one-piece sharps collector hinge cap with petals lids did not fit properly.The following information was provided by the initial reporter, translated from japanese to english: customer reported that the lid did not fit tightly.During product check, it was observed that the lid did not fit.The complaint product was unusable.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 26jun2023.H6: investigation summary : 2 sample(s) received and verified the issue of lid.Customer reported that the lid did not fit tightly.During product check, it was observed that the lid did not fit.The complaint product was unusable was verified.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.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
It was reported that the bd¿ multiuse one-piece sharps collector hinge cap with petals lids did not fit properly.The following information was provided by the initial reporter, translated from japanese to english: customer reported that the lid did not fit tightly.During product check, it was observed that the lid did not fit.The complaint product was unusable.
Additional Manufacturer Narrative
H6: investigation summary 2 sample(s) received and verified the issue of lid.Customer reported that the lid did not fit tightly.During product check, it was observed that the lid did not fit.The complaint product was unusable was verified.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.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.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.The production of the lot 2053002 was in february 2022.The capa was implemented after the lot in question was produced.
Event or Problem Description
It was reported that the bd¿ multiuse one-piece sharps collector hinge cap with petals lids did not fit properly.The following information was provided by the initial reporter, translated from japanese to english: customer reported that the lid did not fit tightly.During product check, it was observed that the lid did not fit.The complaint product was unusable.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17238339
• Report Number: 2243072-2023-01160
• Device Sequence Number: 20575312
• 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,Followup
• Report Date (Section B): 08/09/2023

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
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 07/14/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/03/2023; 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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