MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SLIDE CLOSE 9GAL RED; SHARPS CONTAINERS AND ACCESSORIES

Model Number	305616
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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.Medical device manufacture date : unknown.
Event or Problem Description
It was reported that 1 bd sharps coll slide close 9gal red had broken and damaged lid issues.The following information was provided by the initial reporter : the customer reported that the lid was chipped and was not shut properly.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12-may-2022.H.6.Investigation: bdj received the samples and photos were forwarded the the manufacturing facility.According to the dhr review process, the results showed there were no issues reported like lid broken or damaged during the manufacturing process for the part number reported under this customer complaint.Also, a review of the ncmr¿s was performed; the result showed there were no issues reported like lid broken or damaged for the same part number throughout the last twelve months.Based on the pictures provided from customer it can be seen that the lid is broken from the handle section and also, in the report, customer describes that the lid was chipped and was not shut properly.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 that country 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, 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.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.
Event or Problem Description
It was reported that 1 bd sharps coll slide close 9gal red had broken and damaged lid issues.The following information was provided by the initial reporter : the customer reported that the lid was chipped and was not shut properly.

• Brand Name: SHARPS COLL SLIDE CLOSE 9GAL RED
• Common Device Name: SHARPS CONTAINERS AND ACCESSORIES
• 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: 14466625
• Report Number: 2243072-2022-00722
• Device Sequence Number: 14624279
• Product Code: FMI
• UDI-Device Identifier: 00382903056163
• UDI-Public: 00382903056163
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 305616
• Device Catalogue Number: 305616
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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