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

Model Number	305635
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.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 2 bd¿ phlebotomy sharps collector was missing lids.The following information was provided by the initial reporter: this is a report about missing lids of sharps collector 1.0l.According to the customer's report, two lids were found to be missing.
Additional Manufacturer Narrative
H.6.Investigation summary: no photos or samples were received by the customer.This is a report about missing lids of sharps collector 1.0l.According to the customer's report, two lids were found to be missing could not be verified due to the product not being returned for failure investigation.According to the dhr review process, the result showed there were no issues reported like missing lids during the manufacturing process for the lot number (2257947) reported under this customer complaint.A review of the ncmr¿s was performed; the result showed that no missing lids issues were reported for the same part number throughout the last twelve months.According with this investigation and lot number provided, this product was manufactured by flex on september 14, 2022, however, there is not enough information provided from customer like pictures of original packaging in order to determine the root cause.For this reason, it can be concluded that there are many variables that could generate this failure mode due to unknown handling and transportation, if the material is stored or if there are partial sales.Based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process since information such as method used to handle, shipped partial sells and controls to storage the remaining product within distributor facility is unknown.
Event or Problem Description
It was reported that 2 bd¿ phlebotomy sharps collector was missing lids.The following information was provided by the initial reporter: this is a report about missing lids of sharps collector 1.0l.According to the customer's report, two lids were found to be missing.

• Brand Name: BD¿ PHLEBOTOMY 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16460912
• Report Number: 2243072-2023-00277
• Device Sequence Number: 11348846
• Product Code: FMI
• UDI-Device Identifier: 00382903056354
• UDI-Public: (01)00382903056354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• 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): 03/22/2023

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: 305635
• Device Catalogue Number: 305635
• Device Lot Number: 2257947
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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