MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 19GAL GASKET RED; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305666
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 2 cases of sharps coll 19gal gasket red were missing their lids.The following information was provided by the initial reporter: "the lids are interchangeable and as mentioned previously, we received #2 cases without lids.This equates to #10 containers without lids.".
Event or Problem Description
It was reported that 2 cases of sharps coll 19gal gasket red were missing their lids.The following information was provided by the initial reporter: "the lids are interchangeable and as mentioned previously, we received #2 cases without lids.This equates to #10 containers without lids.".
Additional Manufacturer Narrative
H6: investigation summary: no photo or sample was received with the customer's complaint of missing lids.Without photos or a physical sample for investigation, 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 missing lids during the manufacturing process of the lot number reported (1073905) under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like missing lids issue for the same part number throughout the last twelve months.Potential root cause: 1.Non-controlled method to ship partial boxes to end user (re-packaging process).2.Non controlled handling within distributor facilities.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: SHARPS COLL 19GAL GASKET RED
• 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: 12329015
• Report Number: 2243072-2021-02078
• Device Sequence Number: 20011810
• Product Code: FMI
• UDI-Device Identifier: 50382903056663
• UDI-Public: 50382903056663
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 11/02/2021

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: 305666
• Device Catalogue Number: 305666
• Device Lot Number: 1073905
• 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: 07/19/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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