MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 6GAL RED 1103 NON-VENT CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305457
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 4 sharps coll 6gal red 1103 non-vent cap experienced missing lids.The following information was provided by the initial reporter: material no: 305457, batch no: 8213927.Event description per attached email states, "4 lids missing - 305457 / batch # 8213927".
Additional Manufacturer Narrative
Investigation summary: dhr: according to the dhr review process; the result showed there were no issues reported like missing lids, lid broken and lid closed during the manufacturing process of the lot number reported under this customer complaint.Investigation according with the complaint report and pictures provided, several damages and missing lids were found on the container ordered by the customer.As per complaint problem description, the container was ordered through distributor henry schein which in previous investigations it was confirmed that they are performing an additional repackaging to perform partial sales when flex is using a standard pack required by becton dickinson within the buy specifications.Due to evidence from original box was not provided by customer, it was concluded that there is no enough evidence to determine the root cause of this issue since these kinds of issues could be generated due incorrect handling and/or incorrect packaging.Potential root cause: 1.Non-controlled method to perform repackaging.2.Product damaged during the shipment or distribution.3.Not suitable packaging used to ship partial sales.
Event or Problem Description
It was reported that 4 sharps coll 6gal red 1103 non-vent cap experienced missing lids.The following information was provided by the initial reporter: material no: 305457 batch no: 8213927.Event description per attached email states, "4 lids missing - 305457 / batch # 8213927.".

• Brand Name: SHARPS COLL 6GAL RED 1103 NON-VENT CAP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8600709
• Report Number: 2243072-2019-00900
• Device Sequence Number: 11496739
• Product Code: FMI
• UDI-Device Identifier: 50382903054577
• UDI-Public: 50382903054577
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K943134
• 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): 06/19/2019

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: 305457
• Device Lot Number: 8213927
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/19/2019
• 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