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

Model Number	305551
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.(b)(4).Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd sharps coll next gen 5.4qt clear 20/pack was not received.The customer received the wrong product with the correct label.The following information was provided by the initial reporter: it was reported by the medical professional, the wrong product was received.  customer received wrong item with correct item # label.They order clear container and received 2 cases of the same size red container.
Event or Problem Description
It was reported that bd sharps coll next gen 5.4qt clear 20/pack was not received.The customer received the wrong product with the correct label.The following information was provided by the initial reporter: it was reported by the medical professional, the wrong product was received.  verbatim: customer received wrong item with correct item # label.They order clear container and received 2 cases of the same size red container.
Additional Manufacturer Narrative
H6: investigation summary: according with this investigation and the information provided from the customer a different product (collector) was sent to end user.It is possible that during startup, a complete line clearance was skipped, the product was mixed at the time of start of production (manufacturing process) and during the labeling process it was not detected that different pieces were packed.The result of this investigation is that the mixed component issue is related to the manufacturing process.A dhr review could not be performed since lot number information was not received, the complaint information only contains the family product and item.However, a review of the ncmr¿s was performed; the result showed there were no issues reported for mixed component for the same part number (305551) throughout the previous twelve months.Potential root causes include 1.Scrap material from the previous order was not collected at the end of the shift.2.During the cleaning of the starting line, the material was not collected due to a change of order.3.Incorrect packaging process when starting the product line the supplier updated production line with directions to remove all scrap material from previous orders during production.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• 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
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12751302
• Report Number: 2243072-2021-02660
• Device Sequence Number: 4560453
• Product Code: FMI
• UDI-Device Identifier: 00382903055517
• UDI-Public: 00382903055517
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/24/2022

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: 305551
• Device Catalogue Number: 305551
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown