MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305551
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the label on side of box does not match the label that is on the top with a bd sharps coll¿ next gen 5.4qt clear 20/pack.The following information was provided by the initial reporter: it was reported that the label on the top of the box did not match the label on the side of the box.
Additional Manufacturer Narrative
Dhr/ncmr review dhr review process can¿t be performed due to the lot number was not provided from customer.A review of the ncmr¿s was performed; the result showed there were no issues reported like incorrect product number printed on label for the same part number throughout the last twelve months.Investigation based on the pictures provided from customer the following observations were made: ¿ the label sent to end user doesn¿t belong to flex ¿ a different box was used by distributor (medline) ¿ a re-packaging process is being performed by distributor according with this investigation this failure mode isn¿t related to manufacturing process because the distributor is doing a repackaging process were apparently, they have a different lot to traceability of the product sold to end user.Risk assessment a risk assessment isn¿t needed because there is not a failure mode related to manufacturing process.Root cause re-packaging process performed by distributor corrective action n/a conclusion based on this investigation this failure mode isn¿t related to manufacturing process because the distributor is doing a repackaging process were apparently, they have a different lot number to perform the trace-ability of the product sold to end user.All the complaint information was captured for tracking and trending purposes.H3 other text : see section h.10.
Event or Problem Description
It was reported that the label on side of box does not match the label that is on the top with a bd sharps coll¿ next gen 5.4qt clear 20/pack.The following information was provided by the initial reporter: it was reported that the label on the top of the box did not match the label on the side of the box.

• Brand Name: BD SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9616524
• Report Number: 2243072-2020-00064
• Device Sequence Number: 2830176
• Product Code: FMI
• UDI-Device Identifier: 50382903055512
• UDI-Public: 50382903055512
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 02/17/2020

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: 305551
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 02/17/2020
• 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