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

Model Number	305517
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.(b)(4).Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device expiration date: unknown.
Event or Problem Description
It was reported that the bd¿ sharps collector was missing.The following information was provided by the initial reporter, translated from japanese to english: according to the distributor's report, one lid was found to be missing upon product arrival.
Event or Problem Description
It was reported that the bd¿ sharps collector was missing.The following information was provided by the initial reporter, translated from japanese to english: according to the distributor's report, one lid was found to be missing upon product arrival.
Additional Manufacturer Narrative
Investigation summary: according to the dhr review, during the manufacturing process no issues were reported as missing lids for the lot number (2227941) reported under this complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like missing lid issue for the same part number throughout the last twelve months.According with this investigation there is not enough information provided from customer like pictures of original packaging, however, based on the lot number provided, we are able to confirm that product was manufactured by flex on september 11, 2022.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).Based on information provided it wasn¿t possible determine the root cause like a failure mode related to the manufacturing process because there is not enough information 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, with the lot number provided it was possible to confirm within weight records that every box was manufactured with the correct amount of product.

• 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: 16319684
• Report Number: 2243072-2023-00141
• Device Sequence Number: 8645415
• Product Code: FMI
• UDI-Device Identifier: 00382903055173
• UDI-Public: (01)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): 03/01/2023

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: 305517
• Device Catalogue Number: 305517
• Device Lot Number: 2254933
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/17/2023
• 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