MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 9GAL HINGE PHARMWASTE; SHARPS CONTAINER

Model Number	305634
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the sharps coll 9gal hinge pharmwaste experienced a missing lid or slide lid/clamp the following information was provided by the initial reporter: material no: 305634 batch no: 0067928.It was reported that the lids are missing.
Additional Manufacturer Narrative
H6: investigation summary: a photo representation was received.Also, the evidence of packaging was provided.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 could have caused or contributed to the reported incident, ¿missing lids¿.The photo provided can confirm repackaging and it was identified the product was sold 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 this original box by the weighing system confirms this box was packaged and met specification before release.The root cause is unconfirmed.The issue most likely occurred after manufacturing and during repackaging with a distributor.H3 other text : see h10.
Event or Problem Description
It was reported that the sharps coll 9gal hinge pharmwaste experienced a missing lid or slide lid/clamp.The following information was provided by the initial reporter: material no: 305634 batch no: 0067928.It was reported that the lids are missing.

• Brand Name: SHARPS COLL 9GAL HINGE PHARMWASTE
• Common Device Name: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11189576
• Report Number: 2243072-2021-00136
• Device Sequence Number: 19716033
• Product Code: MMK
• UDI-Device Identifier: 00382903056347
• UDI-Public: 00382903056347
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943134
• 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): 02/10/2021

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: 305634
• Device Catalogue Number: 305634
• Device Lot Number: 0067928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1