MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305609
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 5 bd¿ sharps collectors had broken lids.The following information was provided by the initial reporter: during the inspection at the distributors side, five lids in a carton were found to be all broken.
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: na.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 5 bd¿ sharps collectors had broken lids.The following information was provided by the initial reporter: during the inspection at the distributor's side, five lids in a carton were found to be all broken.
Additional Manufacturer Narrative
Investigation summary: according to the dhr review, during the manufacturing process no issues were reported for damaged or broken lids for the lot numbers reported under this complaint.A review of the ncmr¿s was performed; the results exhibit no issue reported for the same part number and issue throughout the last twelve months.Based on the information provided from customer, there is not enough evidence like a picture showing the defect on the product to determine the root cause, however, with the lot number provided (2024939), we can determine that this product was manufactured by flex on january 24, 2022.Additionally, within the report customer describes that during inspection at the distributor¿s side, five lids in a carton were found to be all broken.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.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.

• Brand Name: BD¿ SHARPS COLLECTOR
• 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: 15635466
• Report Number: 2243072-2022-01791
• Device Sequence Number: 20286250
• Product Code: FMI
• UDI-Device Identifier: 00382903056095
• UDI-Public: 00382903056095
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943575
• 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): 11/04/2022

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: 305609
• Device Catalogue Number: 305609
• Device Lot Number: 2024939
• 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: 09/22/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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