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

Catalog Number	305615
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported that 8 sharps coll 9gal red experienced a missing lid or slide lid/clamp which was noted prior to use.The following information was provided by the initial reporter: material no: 305615 batch no: unknown.Event description: material #: 305615.Lot #: n/a.Po# if available: 4500668709.Quantity: 1 case.Issue with lid ¿ missing lids.
Additional Manufacturer Narrative
H.6.Investigation summary 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.Evidence of original packaging is required.Bd will continue to monitor for any trends.H3 other text : see section h.10.
Event or Problem Description
It was reported that 8 sharps coll 9gal red experienced a missing lid or slide lid/clamp which was noted prior to use.The following information was provided by the initial reporter: material no: 305615 batch no: unknown event description: material #: 305615 lot #: n/a po# if available: 4500668709 quantity: 1 case issue with lid ¿ missing lids.

• Brand Name: SHARPS COLL 9GAL 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9616448
• Report Number: 2243072-2020-00063
• Device Sequence Number: 1802230
• Product Code: FMI
• UDI-Device Identifier: 50382903056151
• UDI-Public: 50382903056151
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: 305615
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 02/17/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown