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

Catalog Number	305603
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.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 chemo 9gal yellow experienced the lid or slide lid/clamp missing.Product defect was noted prior to use.The following information was provided by the initial reporter: material no: 305603 batch no: 9257921.Event description per states: no lids.Product was shipped from distributor to the customer.
Additional Manufacturer Narrative
H.6 investigation summary: a sample and photo representation were received for the investigation.A review of the device history record (dhr) and non-conforming material report (ncmr) for the reported lot was performed for the past 12 months.There were no manufacturing or material defects reported that would have caused or contributed to the reported incident, ¿missing lids¿.The sample provided may confirm repackaging by a distributor.A weighing system has already been implemented as corrective action for this container manufacturing process to ensure the correct quantity of pieces per box before shipping.The weighted label placed on the original box by the weighing system confirmed the issue did not occur during manufacturing.The root cause is inconclusive.The issue may have occurred during repackaging or 3rd party distribution.Bd will continue to monitor for any trends h3 other text : see h.10.
Event or Problem Description
It was reported that 8 sharps coll chemo 9gal yellow experienced the lid or slide lid/clamp missing.Product defect was noted prior to use.The following information was provided by the initial reporter: material no: 305603.Batch no: 9257921.Event description per states: no lids product was shipped from distributor to the customer.

• Brand Name: SHARPS COLL CHEMO 9GAL YELLOW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9589010
• Report Number: 2243072-2020-00033
• Device Sequence Number: 3423073
• Product Code: FMI
• UDI-Device Identifier: 50382903056038
• UDI-Public: 50382903056038
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• 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): 02/13/2020

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: 305603
• Device Lot Number: 9257921
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 02/13/2020
• 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