MAUDE Adverse Event Report: BECTON DICKINSON 64L BD¿ EXTRA LARGE SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305609
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: na.
Event or Problem Description
It was reported that 2 64l bd¿ extra large sharps collector did not come with lids.The following information was provided by the initial reporter: 2 cases did not come with lids.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.It was reported that two cases did not come with lids (lids missing) could not be verified due to the product not being returned for failure investigation.According to the device history record review process, the result showed there were no issues reported like missing lids during the manufacturing process for the lot number (21500963) reported under this customer complaint.A review of the non-confirming material review (ncmr¿s) was performed; the result showed no issue reported for missing lids for the same part number throughout the last twelve months.According with this investigation and lot number provided, this product was manufactured by flex on may 30, 2022, however, there is not enough information provided from customer like pictures of original packaging in order to determine the root cause.
Event or Problem Description
It was reported that 2 64l bd¿ extra large sharps collector did not come with lids.The following information was provided by the initial reporter: 2 cases did not come with lids.

• Brand Name: 64L BD¿ EXTRA LARGE 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: 15441880
• Report Number: 2243072-2022-01532
• Device Sequence Number: 14914120
• Product Code: FMI
• UDI-Device Identifier: 00382903056095
• UDI-Public: 00382903056095
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943575
• 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): 09/23/2022

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: 305609
• Device Catalogue Number: 305609
• Device Lot Number: 2150963
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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