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

Model Number	305609
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd¿ sharps collector had no lid.The following information was provided by the initial reporter, translated from japanese: "according to the customer's report, the product did not come with its lid.".
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Initial reporter phone#: unknown.Initial reporter e-mail: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd¿ sharps collector had no lid.The following information was provided by the initial reporter, translated from japanese: "according to the customer's report, the product did not come with its lid.".
Additional Manufacturer Narrative
H6: investigation summary : no photos or samples were received.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.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.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, lot number, method used to handle material, shipped partial sells and storage controls of the remaining product within distributors facilities to perform an exhaustive investigation.

• 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: 15664361
• Report Number: 2243072-2022-01825
• Device Sequence Number: 6546473
• Product Code: FMI
• UDI-Device Identifier: 00382903056095
• UDI-Public: (01)00382903056095
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: 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: 09/28/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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