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

Model Number	305666
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).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 5 sharps coll 19gal gasket red experienced missing lids or slide lids/clamps.Product defect was noted prior to use.The following information was provided by the initial reporter: material no: 305666 batch no: 9158917.Injuries or adverse event: no reported issue: lids are missing.
Event or Problem Description
It was reported that 5 sharps coll 19gal gasket red experienced missing lids or slide lids/clamps.Product defect was noted prior to use.The following information was provided by the initial reporter: material no: 305666 batch no: 9158917 injuries or adverse event: no reported issue: lids are missing.
Additional Manufacturer Narrative
H.6.Investigation: a photo representation was received.Also, the evidence of packaging was provided.The lids and the instructions for use are not observed in the photos.It was noted that the box is not the original packaging container provided by the manufacturer.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 may confirm repackaging by the 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.Unfortunately, a weighted label placed on the original box by the weighing system is required to identify or confirm this type of issue.The root cause is unconfirmed.The issue most likely occurred during repackaging with a distributor.H3 other text : see h.10.

• 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: 10228893
• Report Number: 2243072-2020-00993
• Device Sequence Number: 594940
• Product Code: FMI
• UDI-Device Identifier: 50382903056663
• UDI-Public: 50382903056663
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K943575
• 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): 07/15/2020

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: 305666
• Device Catalogue Number: 305666
• Device Lot Number: 9158917
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 07/15/2020
• 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