MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR 8QT NEST OPEN TOP NEEDL PORT; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305343
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd sharps collector 8qt nest open top needl port lid broke.The following information was provided by the initial reporter: during the inspection of the product before delivery to a customer, one lid was found to be broken.
Additional Manufacturer Narrative
Correction: h4: device manufacture date: 05-oct-2021.H6: investigation summary: based on the pictures provided from customer, it can be seen the following: ¿ the lid handle is broken.¿ through the lot number, it can be confirmed that this product as manufactured by flex on september 2021.According with this investigation, it was noticed that this issue arose from a product sold in japan and all the shipping and transportation process for that country products indicates that flex is in charge of manufacturing, packaging and loading of the product, while bd is in control of transportation, transshipment, distribution and final delivery.According to the dhr review process, the results showed there were no issues reported like lid broken during the manufacturing process for the lot number reported (1271946) under this customer complaint.Also, a review of the ncmr¿s was performed; the result showed there were no issues reported like lid broken or damaged for the same part number throughout the last twelve months.Based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process because there is not enough information like method used to handle, shipped partial sells and controls to storage the remaining product within distributor facility.The controls were verified within the manufacturing process and confirmed as capable to detect broken or damaged lids.
Event or Problem Description
It was reported that the bd sharps collector 8qt nest open top needl port lid broke.The following information was provided by the initial reporter: during the inspection of the product before delivery to a customer, one lid was found to be broken.

• Brand Name: BD SHARPS COLLECTOR 8QT NEST OPEN TOP NEEDL PORT
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15196419
• Report Number: 2243072-2022-01279
• Device Sequence Number: 2239384
• Product Code: FMI
• UDI-Device Identifier: 50382903053433
• UDI-Public: 50382903053433
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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: 305343
• Device Catalogue Number: 305343
• Device Lot Number: 1271946
• 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: 07/11/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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