MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL 9GAL RED; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305615
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device evaluated by mfr: 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 sharp container did not have a lid with a bd sharps coll 9gal red.The following information was provided by the initial reporter: material no.: 305615, batch no.: unknown.It was reported that the sharps containers did not come with lids.
Event or Problem Description
It was reported that the sharp container did not have a lid with a bd sharps coll 9gal red.The following information was provided by the initial reporter: material no.: 305615 batch no.: unknown.It was reported that the sharps containers did not come with lids.
Additional Manufacturer Narrative
The actual product nor photo representation was provided.A review of the device history record (dhr) was not possible since a lot number could not be provided.Also, 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¿.As corrective action a weighing system has already been implemented for this container manufacturing process to ensure the correct quantity of pieces per box before shipping.Unfortunately, a weighted label placed on the box by the weighing system is required to identify or confirm this issue.The root cause is unknown.The issue could have occurred during distribution if repackaged by a distributor.Based on these findings, our investigation is inconclusive.Bd will continue to monitor for any trends.

• Brand Name: BD SHARPS COLL 9GAL RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8654866
• Report Number: 2243072-2019-01044
• Device Sequence Number: 2340693
• Product Code: FMI
• UDI-Device Identifier: 50382903056151
• UDI-Public: 50382903056151
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K943575
• 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): 06/28/2019

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: 305615
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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