MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 3.3QT RED; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305488
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is pps.This site is an oem manufacturing site.Therefore, bd corporate (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It has been reported that the sharps coll 3.3qt red has been found experiencing molding defects before use.The following has been provided by the initial reporter: material no.305488 batch no.Unknown it was reported the handles are so sharp they can break the skin."the handles are so sharp they can break the skin.".
Additional Manufacturer Narrative
H.6.Investigation: the actual product was not provided.No sample was available for evaluation after several request to the customer were made, and it was confirmed no additional lids with a sharp handle were found.A review of the device history record (dhr) was not possible since a lot number could not be provided.A review of non-conforming material report (ncmr) for the reported container was performed for the past 12 months with no related issues found for a sharp handle or a flash on the handle.Additionally, the last six lots produced were evaluated and all caps were produced free of a hard or sharp flash, which is an area of excess plastic that can be produced during the molding process.The potential root cause is a molding issue but is unconfirmed.Based on these findings, the investigation was inconclusive.
Event or Problem Description
It has been reported that the sharps coll 3.3qt red has been found experiencing molding defects before use.The following has been provided by the initial reporter: material no.305488 batch no.Unknown.It was reported the handles are so sharp they can break the skin."the handles are so sharp they can break the skin.".

• Brand Name: SHARPS COLL 3.3QT RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8898125
• Report Number: 2243072-2019-01724
• Device Sequence Number: 1400691
• Product Code: FMI
• UDI-Device Identifier: 50382903054881
• UDI-Public: 50382903054881
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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: 305488
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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