MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 19GAL GASKET RED; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305666
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: 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.Medical device expiration date: n/a.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 the lid on the sharps coll 19gal gasket red would not close tight and let gas escape during use.The following information was provided by the initial reporter: "problematic at the opening of this container which lets gas escape since it does not close tight".
Additional Manufacturer Narrative
H.6.Investigation: it was reported that the lids do not close completely, that the opening of the container does not close tight allowing gas to escape.No sample or picture was provided for evaluation.A review of the device history record (dhr) and non-conforming material report (ncmr) was performed for the last twelve months there were no issues reported like ¿lid doesn¿t close tight¿ during the manufacturing process.It is possible the arm of a trolley isn¿t properly placed because of a drilled hole on the arm that may be misplaced.This cannot be confirmed however without the sample or pictures of the issue.The root cause was unconfirmed.
Event or Problem Description
It was reported that the lid on the sharps coll 19gal gasket red would not close tight and let gas escape during use.The following information was provided by the initial reporter: "problematic at the opening of this container which lets gas escape since it does not close tight.".

• Brand Name: SHARPS COLL 19GAL GASKET RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9728278
• Report Number: 2243072-2020-00238
• Device Sequence Number: 741206
• Product Code: FMI
• UDI-Device Identifier: 50382903056663
• UDI-Public: 50382903056663
• 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): 03/09/2020

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 Model Number: 305666
• Device Catalogue Number: 305666
• Device Lot Number: 9209930
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/09/2020
• 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