MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL 6.9QT RED VENTED CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305489
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
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 and the franklin lakes fda registration number has been used for the manufacture report number.Device manufacture date: unknown.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 2 of the bd sharps coll 6.9qt red vented cap will not stay shut or cannot close it.The following information was provided by the initial reporter: last three cases have been problematic on the latch, it will not stay shut or you cannot close it.It just keeps popping back up or you cannot get it to latch, cannot put enough pressure to get it to latch.
Additional Manufacturer Narrative
No samples or photos were returned by the customer.It was reported by the customer the latch will not stay shut or you cannot close it.Requirement(s):the temporary close & permanent close should operate as designed.Investigation: no updates were received on this complaint from the customer other than the notification.No pictures or samples were received which limits investigation.A full dhr review was conducted, and no issues were detected during this run.Corrective and/preventive action: a scar was issued to flextronics for non-conforming caps (ncr#769).The supplier¿s response is attached.Conclusion : the original scar event generated a qc alert which went out to the shop floor for the remainder of the run.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
No additional information.

• Brand Name: BD SHARPS COLL 6.9QT RED VENTED CAP
• 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 ; 8015296192
• MDR Report Key: 16219608
• Report Number: 2243072-2023-00050
• Device Sequence Number: 12635451
• Product Code: FMI
• UDI-Device Identifier: 00382903054893
• UDI-Public: (01)00382903054893
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: 305489
• Device Catalogue Number: 305489
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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