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

Catalog Number	305602
Medical Device Problem Codes	Leak/Splash (1354); Defective Device (2588); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter phone #: (b)(6).Initial reporter occupation: (b)(6).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 an unspecified number of sharps coll slide close 9gal gasket red experienced broken/damaged lids, leakage, and device damage/deformation while still considered operable.Product defects were noted after use.The following information was provided by the initial reporter: material no: 305602 batch no: 9098920.Cn called and stated that when the sharp containers are stacked to be disposed the clearview tops are cracking and leaking.
Additional Manufacturer Narrative
H.6.Investigation summary a compliant review was performed by the supplier.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.Photos of the product damaged were provided and according to the pictures received from customer several damages can be seen on the lids and bases which were caused by incorrect handling and misuse.The lids were broken after being stacked onto each other when full and closed.There are no specifications available for stacking of filled containers and no specifications for weight limit resistance over the lids.Tests made by the manufacturer for the lids are limited to lid functionality (assembly top to base, temporary closure, and final closure).The containers are not designed to be stacked for disposal after the use.Bd will continue to monitor the complaint for any trends.
Event or Problem Description
It was reported that an unspecified number of sharps coll slide close 9gal gasket red experienced broken/damaged lids, leakage, and device damage/deformation while still considered operable.Product defects were noted after use.The following information was provided by the initial reporter: material no: 305602 batch no: 9098920 cn called and stated that when the sharp containers are stacked to be disposed the clearview tops are cracking and leaking.

• Brand Name: SHARPS COLL SLIDE CLOSE 9GAL GASKET RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10027055
• Report Number: 2243072-2020-00723
• Device Sequence Number: 14106999
• Product Code: FMI
• UDI-Device Identifier: 50382903056021
• UDI-Public: 50382903056021
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K943575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2020

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: 305602
• Device Lot Number: 9098920
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 05/29/2020
• 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