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

Model Number	305615
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: (b)(4).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.(b)(4).
Event or Problem Description
It was reported that the sharps coll 9gal red experienced a missing lid.The following information was provided by the initial reporter: item: 305615, quantity affected: 1 , customer states all the lids are missing from the case.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-11-25 h6: investigation summary sample and photo representation was provided.The issue was confirmed and there was missing lids with sample not packaged according to specification however we could not confirm the root cause.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids during the manufacturing process of the reported lot.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance.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.All weight checks for this lot appear to have met requirements at the time of manufacturing.The root cause is unknown.H3 other text : see h.10.
Event or Problem Description
It was reported that the sharps coll 9gal red experienced a missing lid.The following information was provided by the initial reporter: item: 305615 quantity affected: 1 customer states all the lids are missing from the case.

• 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
• MDR Report Key: 11064646
• Report Number: 2243072-2020-02125
• Device Sequence Number: 2876424
• Product Code: FMI
• UDI-Device Identifier: 00382903056156
• UDI-Public: 00382903056156
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: 305615
• Device Catalogue Number: 305615
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1