MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SIDE ENTRY 5.4QT RED; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305443
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(6) has been listed and the (b)(6) fda registration number has been used for the manufacture report number.Medical device expiration date: na.The customer's address is unknown.New jersey (nj), usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that sharps coll side entry 5.4qt red had incorrect label information.The following information was provided by the initial reporter: material no: 305443 batch no: 0357920 it was reported via email: customer received an item with a lot labeling issue.
Additional Manufacturer Narrative
The initial report was made in error.The reported malfunction of the device is not reasonably anticipated to cause or contribute to a death or serious injury if it were to recur.Please consider the mdr cancelled.
Event or Problem Description
It was reported that sharps coll side entry 5.4qt red had incorrect label information.The following information was provided by the initial reporter: material no: 305443 batch no: 0357920.It was reported via email: customer received an item with a lot labeling issue.

• Brand Name: SHARPS COLL SIDE ENTRY 5.4QT RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11382570
• Report Number: 2243072-2021-00620
• Device Sequence Number: 3984891
• Product Code: FMI
• UDI-Device Identifier: 00382903054435
• UDI-Public: 00382903054435
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• 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): 05/19/2021

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: 305443
• Device Catalogue Number: 305443
• Device Lot Number: 0357920
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1