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

Catalog Number	305601
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
Material no.305601, batch no.9033926.It was reported that before use of the sharps coll 9gal gasket red sharps containers were missing lids.The following information was provided by the initial reporter: reported a defective sharps containers on 5/9 and was advised that a replacement would be shipped to our customer.The lot number is 9033926 and the customer was missing the lids.
Event or Problem Description
Material no.305601.Batch no.9033926.It was reported that before use of the sharps coll 9gal gasket red sharps containers were missing lids.The following information was provided by the initial reporter: reported a defective sharps containers on 5/9 and was advised that a replacement would be shipped to our customer.The lot number is 9033926 and the customer was missing the lids.
Additional Manufacturer Narrative
H.6.Investigation: a sample and photo representation were received for the investigation.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 would have caused or contributed to the reported incident, ¿missing lids¿.The sample provided may confirm repackaging by a 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.The weighted label placed on the original box by the weighing system confirmed the issue did not occur during manufacturing.The root cause is inconclusive.H3 other text : see h.10.

• Brand Name: SHARPS COLL 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: 8703658
• Report Number: 2243072-2019-01192
• Device Sequence Number: 2090719
• Product Code: FMI
• UDI-Device Identifier: 50382903056014
• UDI-Public: 50382903056014
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K943575
• 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): 07/10/2019

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: 305601
• Device Lot Number: 9033926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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