MAUDE Adverse Event Report: BECTON DICKINSON 34L BD¿ LARGE SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305601
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.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 the34l bd¿ large sharps collector were missing lids.The following was received by the initial reporter: injuries or adverse event: no.Reported issue: customer received sealed box - no lids, only containers.No damage tobox.
Event or Problem Description
It was reported that the34l bd¿ large sharps collector were missing lids.The following was received by the initial reporter: injuries or adverse event: no reported issue: customer received sealed box - no lids, only containers.No damage tobox.
Additional Manufacturer Narrative
No photos or samples were received.Additional attempt to get more information were made, however, regional team confirmed that no additional information was available.Based on the information provided, the dhr review process was unable to be performed since there was no lot number provided.A review of the ncmr¿s was performed; the result showed no issues reported for missing lids for the same part number throughout the last twelve months.According with this investigation there is not enough information provided from customer such as lot number or pictures of the original packaging in order to determine the root cause of this issue.The variables that could generate this failure mode such as handling, transportation, storage or partial sales from distributor are unknown.Additional information is required to discard issue was generated by distributor facility, since partial sells and controls to handle remaining material is unknown, therefore, the likelihood of sending boxes with incorrect quantity exist.In addition, the current manufacturing controls were reviewed, and confirmed the capability to detect this type of issue (missing lids).As part of this investigation, a review of customer complaint records was performed; according to the cc¿s records, only one additional complaint was received through the last twelve months for the same part number and issue.This previous complaint was closed as non-manufacturing related due to the evidence received.Weight history records results: since no lot number was provided, weighing database was not able to be evaluated order to verify if every manufactured box was packaged with the correct number of lids at the time to perform the packaging process.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.Non-controlled handling within distributor facilities.Conclusion: based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process since information such as method used to handle, shipped partial sells and controls to storage the remaining product within distributor facility is unknown.The controls were verified within the manufacturing process and confirmed as capable to detect the reporting failure mode (missing lids).Additionally, there was not lot number provided to verify within the weighing system records if every box manufactured was packed with the correct number of products.

• Brand Name: 34L BD¿ 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17786265
• Report Number: 2243072-2023-01691
• Device Sequence Number: 20362019
• Product Code: FMI
• UDI-Device Identifier: 00382903056019
• UDI-Public: (01)00382903056019
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 10/15/2023

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: 305601
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/15/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/22/2023
• 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