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

Model Number	305488
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd¿ sharps collector hinge cap with petals had a broken lid.This occurred with 6 sharps collectors.The following information was provided by the initial reporter, translated from japanese: "the customer reported that multiple lids were found to be broken.".
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is premium plastic solutions.This site is an oem manufacturing site.(b)(4).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 or Problem Description
It was reported that the bd¿ sharps collector hinge cap with petals had a broken lid.This occurred with 6 sharps collectors.The following information was provided by the initial reporter, translated from japanese: "the customer reported that multiple lids were found to be broken.".
Additional Manufacturer Narrative
H.6.Investigation summary: no samples but photos were returned by the customer.The customer reported that multiple lids were found to be broken 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.Investigation: once pictures were reviewed at upl it was discovered that this issue had the same rc as pr id: 6416547 for lot# 2153001 (around the same time frame, early mid 2022).The lids were simply not snapped onto the containers.This process must happen when the bottles and caps are hot.It is normal practice to heat the caps prior for ease of assembly, however the lids should have been fully seated/assembled onto the bottles during the production run.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.Conclusion : this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: BD¿ 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: 16449880
• Report Number: 2243072-2023-00269
• Device Sequence Number: 17497026
• Product Code: FMI
• UDI-Device Identifier: 00382903054886
• UDI-Public: 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): 04/17/2023

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: 02/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 04/26/2023
• 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): No
• 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