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

Model Number	305517
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
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.Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device expiration date: unknown.
Event or Problem Description
It was reported that 2 bd¿ sharps collector had no lids.The following information was provided by the initial reporter: customer is missing two lids.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported by the customer that they are missing two lids could not be verified due to the product not being returned for failure investigation.According to the dhr review, during the manufacturing process no issues were reported as missing lids for the lot number (2227941) reported under this complaint.A review of the ncmr¿s was performed; the result showed there was one issue reported for missing lids for the same part number throughout the last twelve months.Based on information provided it wasn¿t possible determine the root cause like a failure mode related to the manufacturing process because there is not enough information like a picture from original packaging to perform an exhaustive investigation.The current process controls were verified and confirmed as capable to detect missing lids.H3 other text : see h10.
Event or Problem Description
It was reported that 2 bd¿ sharps collector had no lids.The following information was provided by the initial reporter: customer is missing two lids.

• Brand Name: BD¿ SHARPS COLLECTOR
• 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: 16278788
• Report Number: 2243072-2023-00103
• Device Sequence Number: 6390936
• Product Code: FMI
• UDI-Device Identifier: 00382903055173
• UDI-Public: (01)00382903055173
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• 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): 02/21/2023

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: 305517
• Device Catalogue Number: 305517
• Device Lot Number: 2227941
• 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: 01/11/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• 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