MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD SHARPS DISPOSAL; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305487
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 bd sharps disposal was damaged.The following information was received by the initial reporter in japanese with the verbatim: the customer reported that the lid was broken.
Event or Problem Description
It was reported that bd sharps disposal was damaged.The following information was received by the initial reporter in japanese with the verbatim: the customer reported that the lid was broken.
Additional Manufacturer Narrative
H.6.Investigation summary: one sample of mat# 305487 received, and issue verified.Sample photos send to manufacturer for further investigation and response received.According to the device history record review, during the manufacturing process no issues were reported for damaged or broken lids for the lot number 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.Investigation: based on this investigation, with picture provided as evidence it can be seen that the lid is cracked/damaged, additionally, with lot number provided, we are able to confirm that this product was manufactured by flex on february 23, 2023.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 asia pacific 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.For this reason, it can be concluded that products sold out of usa goes through different distribution stages where this kind of issue may be generated due to handling carried out during the transportation and those activities are out of flex¿s reach.Considering that failure mode is related to broken 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 damages.Based on that assessment, it can be confirmed that the issue could be generated by several variables like hit, incorrect handling, incorrect storage or non-suitable packaging during partial sells.As part of this investigation, a review of customer complaint records was performed; according to the cc¿s records, two additional complaints were received through the last twelve months for the same part number and issue.These previous complaints were closed as incomplete since there was not enough information to determine the root cause.As per the sample being received, an investigation was performed, and a root cause could be determined as potential root cause: product damaged during the transshipped process made by bd¿s second provider.Non-controlled method to ship partial boxes to end user.Product damaged during the shipment or distribution.Incorrect repackaging at the time to perform partial sales.Conclusion: based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process because there was 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.If additional information that helps to find 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 also 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.

• Brand Name: BD SHARPS DISPOSAL
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17806819
• Report Number: 2243072-2023-01707
• Device Sequence Number: 7183920
• Product Code: FMI
• UDI-Device Identifier: 00382903054879
• UDI-Public: (01)00382903054879
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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 Catalogue Number: 305487
• Device Lot Number: 3053973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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