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

Catalog Number	305488
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is premium plastic solutions.This site is an oem manufacturing site.(b)(4).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8207002; device manufacture date: 2018-08-15.Medical device lot #: 8177001; device manufacture date: 2018-07-06.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a lid malfunction occurred with a sharps coll 3.3qt red.The following information was provided by the initial reporter, "the lid didn't shut properly.".
Additional Manufacturer Narrative
H.6.Investigation summary: without a sample or photo it is not possible to do an investigation of the cap that does not shut properly.However we have reviewed complaint with all personnel and reviewed dhr with no findings.H3 other text : see section h.10.
Event or Problem Description
It was reported that a lid malfunction occurred with a sharps coll 3.3qt red.The following information was provided by the initial reporter, "the lid didn't shut properly.".

• 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: 8584282
• Report Number: 2243072-2019-00863
• Device Sequence Number: 16714657
• Product Code: FMI
• UDI-Device Identifier: 50382903054881
• UDI-Public: 50382903054881
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• 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): 07/09/2019

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: SEE H.10
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 07/09/2019
• 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