MAUDE Adverse Event Report: BECTON DICKINSON BD¿ NEXT GENERATION PATIENT / EXAM ROOM SHARPS COLLECTOR, 5.1L; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305517
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.D.4 device expiration date: na.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¿ next generation patient / exam room sharps collector, 5.1l was missing lids.The following was received by the initial reporter: missing lid.
Event or Problem Description
It was reported that the bd¿ next generation patient / exam room sharps collector, 5.1l was missing lids.The following was received by the initial reporter: missing lid.
Additional Manufacturer Narrative
H.6.Investigation summary: no photos or samples were received.Additional attempts to get more information were made, however in none of the cases additional information was retrieved.Dhr review process was not able to be performed since there was no lot number provided to verify if there were issues reported like missing lids during the manufacturing process.A review of the ncmr¿s was performed; the result showed no issues for the same part number and issue throughout the last twelve months.Investigation: according with this investigation there is not enough information provided from customer like pictures of original packaging or lot number.For this reason, it can be concluded that there are many variables that could generate this failure mode due to unknown handling and transportation or if the material is stored or there are partial sales.Additional information is needed about the handling and storage within distributor facility to rule out that this issue was generated by distributors, because the distributors can do partial sells and the controls to handle remaining material is unknown, therefore, the likelihood that they send boxes with incorrect quantity could happen.In addition, the current manufacturing controls were reviewed, and they were confirmed as capable to detect this kind of issues (missing lids).As part of this investigation a review of customer complaint records was performed; according with the cc¿s records, five additional complaints were received through the last twelve months for the same part number and issue.These previous complaints were closed as non-manufacturing related since based on the lot numbers provided, it was possible to review the weighing database and confirmed that every box was packaged with the correct amount of product and there was not enough information in order to determine the root cause.Weight records the weighing database was not able to be evaluated to confirm if every box manufactured was packaged with the correct quantity of components since there was no lot number provided.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: 1.Non-controlled method to ship partial boxes to end user (re-packaging process).2.Product damaged during the shipment or distribution (inappropriate handling).Conclusion: based on information provided it wasn¿t possible to determine the root cause like a failure mode related to the manufacturing process since there was not enough information provided like a picture from original packaging to perform an exhaustive investigation.The current process controls were verified and confirmed as capable to detect missing lids.Additionally, no lot number was provided to confirm within weight records that every box was manufactured with the correct amount of product.If additional information like a photo of original packaging used 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¿ NEXT GENERATION PATIENT / EXAM ROOM SHARPS COLLECTOR, 5.1L
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17597667
• Report Number: 2243072-2023-01484
• Device Sequence Number: 17983177
• Product Code: FMI
• UDI-Device Identifier: 00382903055173
• UDI-Public: (01)00382903055173
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 305517
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/16/2023
• 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