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

Model Number	305609
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the 64l bd¿ extra large sharps collector somehow two lids became faulty.The following information was provided by the initial reporter: we typically order your 19-gallon sharp containers from owens and minor and medline.Somehow two lids became faulty for our staff here and we discarded them.Now we are left with two containers that do not have lids, which presents a problem for us should we get a health code audit.
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as flextronics is an oem manufacturing site.Medical device expiration date: unknown.Device manufacture date: unknown.
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.The customer complaint of lid broken/damaged could not be verified due to the product not being returned for failure investigation.According to the dhr review process, the result showed there were no issues reported as lid damaged during the manufacturing process for the part number reported under this complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid broken for the same part number throughout the last twelve months.
Event or Problem Description
It was reported that while using the 64l bd¿ extra large sharps collector somehow two lids became faulty.The following information was provided by the initial reporter: we typically order your 19-gallon sharp containers from (b)(4).Somehow two lids became faulty for our staff here and we discarded them.Now we are left with two containers that do not have lids, which presents a problem for us should we get a health code audit.

• Brand Name: 64L BD¿ EXTRA LARGE SHARPS COLLECTOR
• Common Device Name: HYPODERMIC 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: 15183972
• Report Number: 2243072-2022-01240
• Device Sequence Number: 17777379
• Product Code: FMI
• UDI-Device Identifier: 00382903056095
• UDI-Public: 00382903056095
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/31/2022

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: 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: 07/11/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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