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

Model Number	305343
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
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 the bd sharps collector had a lid that was cracked.The following information was provided by the initial reporter: verbatim: customer reported that the lid of the product was cracked.
Additional Manufacturer Narrative
H.6.Investigation summary: the actual sample is unavailable for investigation.Photo is provided for verification and investigation performed by manufacturer.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 ( (b)(4) ).A review of the non-conformance material report 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 and information provided, with lot number provided we are able to identify that this product was manufactured by flex on november 4, 2021, and customer reported that the lid of the product was cracked, however, it¿s mentioned only one unit and the standard pack for this product is 20 pieces per box.Additionally, 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/non-manufacturing related since there was not enough information in order to determine the root cause.Due to no sample being received, an investigation could be performed on basis of photo representation, and a root cause could be determined as potential root cause as below: ¿ 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 is 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.
Event or Problem Description
It was reported that the bd sharps collector had a lid that was cracked.The following information was provided by the initial reporter: verbatim: customer reported that the lid of the product was cracked.

• Brand Name: BD SHARPS COLLECTORS
• 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: 17302327
• Report Number: 2243072-2023-01199
• Device Sequence Number: 17901428
• Product Code: FMI
• UDI-Device Identifier: 50382903053433
• UDI-Public: (01)50382903053433
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943134
• 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): 08/04/2023

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: 305343
• Device Catalogue Number: 305343
• Device Lot Number: 1308947
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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