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

Catalog Number	305435
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.Date of event: unknown.The date received by manufacturer has been used for this field.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 the lid was missing with a bd sharps coll 2gal red.This occurred with 6 containers and as discovered prior to use.The following information was provided by the initial reporter: it was reported that six lids were missing when the shipment was received.
Additional Manufacturer Narrative
H.6.Investigation: the actual product nor photo representation was provided.Also, a review of the device history record (dhr) was not possible since a lot number could not be provided.However, a review of non-conforming material report (ncmr) for the reported container was performed for the past 12 months and no manufacturing or material defects were identified that could have caused or contributed to the reported incident, ¿missing lids¿.The weighing system has already been implemented for this containers manufacturing process to ensure the correct quantity of pieces per box before shipping.However, without the weighted label from the outermost box a root cause cannot be identified at this time.Unfortunately, the weighted label is required to identify or confirm this issue.Based on these findings, our investigation is inconclusive.
Event or Problem Description
It was reported that the lid was missing with a bd sharps coll 2gal red.This occurred with 6 containers and as discovered prior to use.The following information was provided by the initial reporter: it was reported that six lids were missing when the shipment was received.

• Brand Name: BD SHARPS COLL 2GAL RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9868126
• Report Number: 2243072-2020-00467
• Device Sequence Number: 16848473
• Product Code: FMI
• UDI-Device Identifier: 50382903054355
• UDI-Public: 50382903054355
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (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): 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305435
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/02/2020
• 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