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

Model Number	305517
Medical Device Problem Codes	Fitting Problem (2183); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical 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.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd¿ sharps collector lid latch was deformed and couldn't be assembled onto the collector.The following information was provided by the initial reporter, translated from (b)(6): "this is a report about a deformed lid of sharps collector.According to the customer's report, the lid was deformed and it could not be assembled.".
Additional Manufacturer Narrative
H.6.Investigation: pictures were received and the sample was sent to the manufacturer.According to the dhr review process, the result showed there were no issues reported as lid deformed (broken / damaged) during the manufacturing process for the part number reported under this complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid deformed (broken / damaged) for the same part number throughout the last twelve months.According with this investigation, customer issue description mentions that ¿lid was deformed and it could not be assembled¿.Based on that statement and the pictures received (from end user and sample sent), it can be confirmed that the lid is deformed (bent), however it was noticed that this issue arose from a product sold in japan and all the shipping and transportation process for that country products indicates that flex is in charge of manufacturing, packaging and loading of the product, while bd is in control of the transportation, transshipment, distribution and final delivery.For this reason, in can be concluded that products sold out of usa goes through different distribution stages where this kind of issue may be generated due to the handling carried out during the transportation and those activities are out of flex¿s reach.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.Based on that assessment, it can be confirmed that issue could be generated by several variables like hit, incorrect handling, incorrect storage, non-suitable packaging during partial sells.All the complaint information was captured also for tracking and trending purposes.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd¿ sharps collector lid latch was deformed and couldn't be assembled onto the collector.The following information was provided by the initial reporter, translated from japanese: "this is a report about a deformed lid of sharps collector.According to the customer's report, the lid was deformed and it could not be assembled.".

• Brand Name: BD¿ 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14160432
• Report Number: 2243072-2022-00513
• Device Sequence Number: 2943810
• Product Code: FMI
• UDI-Device Identifier: 00382903055173
• UDI-Public: 00382903055173
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943141
• 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): 05/23/2022

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: 305517
• Device Catalogue Number: 305517
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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