MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL 6GAL RED 1103 NON-VENT CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305457
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.
Event or Problem Description
It was reported when using the bd sharps coll 6gal red 1103 non-vent cap, the device experienced missing lids.The following information was provided by the initial reporter.The customer stated: it was reported that :received product with incorrect lids verbatim:1 case of 14 826 68b received with incorrect lids.Returning to nwd via ars.Replacement order on (b)(4).
Additional Manufacturer Narrative
Investigation summary: no photos or samples were received with the customer's complaint of incorrect lids.Without further information like a physical sample, the complaint cannot be verified and the root cause remains unknown.According to the dhr review process, the result showed there were no issues reported like incorrect lids during the manufacturing process of the lot numbers reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like incorrect lids issue for the same part number throughout the last twelve months.
Event or Problem Description
It was reported when using the bd sharps coll 6gal red 1103 non-vent cap, the device experienced missing lids.The following information was provided by the initial reporter.The customer stated: it was reported that :received product with incorrect lids verbatim:1 case of 14 826 68b received with incorrect lids.Returning to nwd via ars.Replacement order on (b)(4).

• Brand Name: BD SHARPS COLL 6GAL RED 1103 NON-VENT 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12820329
• Report Number: 2243072-2021-02721
• Device Sequence Number: 14691814
• Product Code: FMI
• UDI-Device Identifier: 00382903054572
• UDI-Public: 00382903054572
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943134
• 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): 01/24/2022

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: 305457
• Device Catalogue Number: 305457
• Device Lot Number: 1107916
• 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: 10/18/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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