MAUDE Adverse Event Report: BECTON DICKINSON BD¿ PHLEBOTOMY SHARPS CONTAINER WITH NEEDLE PORTS; 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	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd¿ phlebotomy sharps container with needle ports were missing 9 lids.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that lids were missing.
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 in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: na h.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: no photos or samples were received.Additional attempts to get more information were made, however customer confirmed there was no additional information available.According to the device history record review, during the manufacturing process no issues were reported for missing components (lids) for the lot number reported under this complaint ((b)(4)).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.Investigation: according with this investigation there is not enough information provided from customer such as pictures of the original packaging in order to determine the root cause of this issue, however, based on lot number, we are able to confirm that product was manufactured by flex on december 8, 2022.The variables that could generate this failure mode such as handling, transportation, storage or partial sales from distributor are unknown.Additional information is required to discard issue was generated by distributor facility, since partial sells and controls to handle remaining material is unknown, therefore, the likelihood of sending boxes with incorrect quantity exist.In addition, the current manufacturing controls were reviewed, and confirmed the capability to detect this type of issue (missing lids).As part of this investigation, a review of customer complaint records was performed; according to the cc¿s records, five additional complaints were received through the last twelve months for the same part number and issue.These previous complaints were closed as non-manufacturing related and incomplete since there was not enough information provided from customer to determine the root cause.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.However potential root cause will be: 1.Non-controlled method to ship partial boxes to end user (re-packaging process).2.Non-controlled handling within distributor facilities.Conclusion 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 picture of the original packaging, method used to handle, shipped partial sells and controls to storage the remaining product within distributor facility is unknown.The controls were verified within the manufacturing process and confirmed as capable to detect the reported failure mode (missing lids) and no issues were found during the manufacturing process of the lot number reported.If additional information that would help to determine the root cause can be provided, then a new complaint record will be open to initiate a new investigation path.All the complaint information was captured for tracking and trending purposes.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.
Event or Problem Description
It was reported that the bd¿ phlebotomy sharps container with needle ports were missing 9 lids.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that lids were missing.

• Brand Name: BD¿ PHLEBOTOMY SHARPS CONTAINER WITH NEEDLE PORTS
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17339366
• Report Number: 2243072-2023-01247
• Device Sequence Number: 17777953
• 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): 08/08/2023

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: 2342947
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• 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