MAUDE Adverse Event Report: BECTON DICKINSON BD 2 SHARPS COLL 5GAL RED 1103 VENTED CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305491
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).
Event or Problem Description
It is reported that prior to use the vented cap is missing with bd 2 sharps coll 5gal red 1103 vented cap.The following information was provided by the initial reporter: it was reported that containers are missing the plastic stopper piece to prevent anyone from putting their hands inside.
Additional Manufacturer Narrative
After further review mfr# 2243072-2020-01428 has been determined to be not reportable.The product was reported to be missing a plastic stopper piece to prevent anyone from putting their hands inside.This product does not come with a stopper.General dissatisfaction of the product does not impact the intended use of the device which would not lead to serious injury or harm to the clinician or patient.Mfr# 2243072-2020-01428 is void.
Event or Problem Description
It is reported that prior to use the vented cap is missing with bd 2 sharps coll 5gal red 1103 vented cap.The following information was provided by the initial reporter: it was reported that containers are missing the plastic stopper piece to prevent anyone from putting their hands inside.

• Brand Name: BD 2 SHARPS COLL 5GAL RED 1103 VENTED CAP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10538754
• Report Number: 2243072-2020-01428
• Device Sequence Number: 14193978
• Product Code: FMI
• UDI-Device Identifier: 00382903054916
• UDI-Public: 00382903054916
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: 305491
• Device Catalogue Number: 305491
• Device Lot Number: 0121001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other