MAUDE Adverse Event Report: BECTON DICKINSON 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	02/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.The reported lot # 0252741 was not found for the reported catalog # 305457.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported sharps coll 6gal red 1103 non-vent cap was missing lids.The following information was provided by the initial reporter: "we have several 6gal sharps containers without lids.".
Event or Problem Description
It was reported sharps coll 6gal red 1103 non-vent cap was missing lids.The following information was provided by the initial reporter: "we have several 6gal sharps containers without lids.".
Additional Manufacturer Narrative
H.6.Investigation: a sample was received and tested by our quality team.There were no lids included in the shipment and the customer's complaint has been verified.The investigation was then forwarded to the supplier for further investigation.According to the dhr review process, the result showed there were no issues reported as missing lids during the manufacturing process for the lot number reported (1244949).A review of the ncmr¿s was performed; the result showed there were no issues reported like missing lids for the same part number throughout the last twelve months.The root cause remains unknown but possible root causes are: 1.Non-controlled method to ship partial boxes to end user (re-packaging process).2.Non-controlled handling within distributor facilities.H3 other text : see h.10.

• Brand Name: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13765127
• Report Number: 2243072-2022-00348
• Device Sequence Number: 14406049
• Product Code: FMI
• UDI-Device Identifier: 00382903054572
• UDI-Public: 00382903054572
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 05/23/2022

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: 305457
• Device Catalogue Number: 305457
• Device Lot Number: 0252741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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