MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 14QT RED 1103 NON-VENT CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305456
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: (b)(4).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 that 9 sharps coll 14qt red 1103 non-vent cap lids were damaged/broken.The following information was provided by the initial reporter, translated from (b)(6) to english: "the customer reported that the product had arrived with the lid shut.".
Additional Manufacturer Narrative
H6: investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history review could not be completed as no batch number was provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.H3 other text : see h10.
Event or Problem Description
It was reported that 9 sharps coll 14qt red 1103 non-vent cap lids were damaged/broken.The following information was provided by the initial reporter, translated from japanese to english: "the customer reported that the product had arrived with the lid shut.".

• Brand Name: SHARPS COLL 14QT 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: 12547114
• Report Number: 2243072-2021-02406
• Device Sequence Number: 14324736
• Product Code: FMI
• UDI-Device Identifier: 00382903054565
• UDI-Public: 00382903054565
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 305456
• Device Catalogue Number: 305456
• 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: 09/01/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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