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

Model Number	305635
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: 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.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 the bd¿ phlebotomy sharps container lid port was damaged by the pen needle.The following information was provided by the initial reporter, translated from japanese to english: "after using the pen needle (cat#320559), the user used the needle port of sharps collector to remove the pen needle from the pen, but the needle was not removed properly from the pen with the needle broken and stayed with the pen.".
Additional Manufacturer Narrative
H6: investigation summary no photos or samples were received.Additional attempt to get more information were made, however, the customer confirmed that no additional information was available.Dhr's review process could not be performed to verify if there were any reported issues such as broken or damaged cap during the manufacturing process, as the lot number was not provided.Based on this investigation and evidence provided, customer verbatim within global complaint detail report is that ¿after using the pen needle (cat#320559), the user used the needle port of sharps collector to remove the pen needle from the pen, but the needle was not removed properly from the pen with the needle broken and stayed with the pen¿.With that explanation and to determine the root cause of this problem, additional information is required such as picture of the product, lot number and method followed.As part of our manufacturing process, we include an ifu (instructions for use) in each box in order to give customer the indications of how to properly use the product.In the ifu¿s is indicated where to insert the appropriate needle detachment port depending on which material is going to be thrown out.However, if the method established is not followed as intended, then it will not function correctly.Considering that failure mode is related to broken/damaged parts, the mold was verified to rule out that the issue could be generated by a damaged on the mold, the assessment confirms that mold was free of damaged.As part of this investigation, a review of customer complaint records was performed; according with the cc¿s records, no additional complaints were received through the last twelve months for the same part number and issue, for this reason, this is considered an isolated issue.Root cause unknown conclusion based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process since there was not enough information like method used to manage product.As part of our manufacturing process, we include an ifu (instructions for use) in each box in order to give customer the indications of how to properly use the product.In the ifu¿s is indicated where to insert the appropriate needle detachment port depending on which material is going to be throw out.However, if the method established is not followed as intended then it will not function correctly.The controls were verified within the manufacturing process and confirmed as capable to detect broken or damaged lids.H3 other text : see h10.
Event or Problem Description
It was reported that the bd¿ phlebotomy sharps container lid port was damaged by the pen needle.The following information was provided by the initial reporter, translated from japanese to english: "after using the pen needle (cat#320559), the user used the needle port of sharps collector to remove the pen needle from the pen, but the needle was not removed properly from the pen with the needle broken and stayed with the pen.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16415090
• Report Number: 2243072-2023-00250
• Device Sequence Number: 14294005
• Product Code: FMI
• UDI-Device Identifier: 00382903056354
• UDI-Public: 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): 03/10/2023

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: 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: 01/25/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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