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

Catalog Number	305615
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: unknown.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.
Event or Problem Description
It was reported that there were 2 occurrences of lid damage with a bd sharps coll¿ 9gal red.The following information was provided by the initial reporter: it was reported that one lid is broken and the second one looks like it is completely shut.
Event or Problem Description
It was reported that there were 2 occurrences of lid damage with a bd sharps coll¿ 9gal red.The following information was provided by the initial reporter: it was reported that one lid is broken and the second one looks like it is completely shut.
Additional Manufacturer Narrative
H.6.Investigation: a compliant review was performed by the supplier.An investigation was performed to review the issue of lid broken and lid shut.Unfortunately, a dhr review cannot be completed because the part number and lot number provided do not belong to the physical product shown in the pictures provided.A nonconformance review showed there were no issues observed for lid broken or lid shut.Since both lids shown in the pictures provided did not belong to part number reported additional evidence would be needed to investigate the issue with this discrepancy.Any additional pictures to provide evidence of the original packaging with containers would also be required.It is possible that the damage occurred in transit during shipping or during the package handling.The root cause was unknown.

• Brand Name: BD SHARPS COLL¿ 9GAL RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8514636
• Report Number: 2243072-2019-00725
• Device Sequence Number: 19207824
• Product Code: FMI
• UDI-Device Identifier: 50382903056151
• UDI-Public: 50382903056151
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/10/2019

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: 305615
• Device Lot Number: 8348913
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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