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

Model Number	305609
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 bd¿ extra large sharps collector lids were closed and cannot be opened.The following information was provided by the initial reporter: reported issue: customer reported that 2 of our lids were closed and cannot be opened.
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.D.4 device expiration date: unknown.H.4 device manufacture date: unknown.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 in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.
Additional Manufacturer Narrative
H6: investigation summary : according with this investigation, there is not enough information provided like a picture showing the defect, however in the issue description it is mentioned that lids were closed and cannot be opened.Therefore, based on the information received from the customer, it was concluded that this product could have been handled by a distributor/representative company since the standard package for this part number corresponds to 5 pieces and the occurrence reported under this complaint mentions two products.There are many variables that could generate this failure mode because the distributors can do partial sells and the controls to handle remaining material is unknown, therefore, the likelihood of non-controlled handling within distributor facilities could happen.There are many variables that could generate this failure mode since distributors can make partial sales and the controls to handle the remaining material are unknown, therefore, the probability of uncontrolled handling within the distributor's facilities could occur, in addition this could also be related to user misuse for not following the steps indicated in ifu.By other hand, the likelihood to send material in close position by flex is not possible since there are controls to avoid this kind of issue.The product sent by flex is being packaged in sets of lids (5 lids per set) secured with a plastic strap which doesn¿t allow the permanent or final closure of the sliding door, once the lids are secured with the plastic strap they are placed into the bases with the sliders oriented toward the bottom of the container, additionally all material is 100% visually inspected by production department and additional random inspection (sample based on aql sampling plan) is performed by a quality inspector.As part of this investigation, a review of customer complaint records was performed; according to the cc¿s records, four additional complaints were received through the last twelve months for the same part number and issue.There previous complaints were closed as non-manufacturing.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.However potential root cause will be: non-controlled handling of the product within distributors facilities.Non-controlled method to ship partial boxes to end user (re-packaging process).End user misuse (the end user didn¿t follow the steps stated in the bd sharps collector ifu).Incorrect expectation from the end user.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 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 closed lids since as part of the manufacturing process they are being packaged in sets of lids (5 lids per set) secured with a plastic strap which doesn¿t allow the permanent or final closure of the sliding door.Also, 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.Additionally, all material is being 100% inspected by production department before packaging to make sure the packaging configuration has been done as indicated in order to avoid closed 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.
Event or Problem Description
It was reported that 2 bd¿ extra large sharps collector lids were closed and cannot be opened.The following information was provided by the initial reporter: reported issue: customer reported that 2 of our lids were closed and cannot be opened.

• Brand Name: BD¿ EXTRA LARGE 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17032874
• Report Number: 2243072-2023-00931
• Device Sequence Number: 15206701
• Product Code: FMI
• UDI-Device Identifier: 00382903056095
• UDI-Public: (01)00382903056095
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K943575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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: 305609
• Device Catalogue Number: 305609
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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