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

Catalog Number	305343
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
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.Therefore, bd corporate headquarters in franklin (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¿ multi-use nestable sharps collector had no label on it.The following information was provided by the initial reporter, translated from japanese: "this is a report about a missing label of sharps collector.During the inspection of products after unpacking at the customer's side, no label was affixed to one of 24 products.".
Additional Manufacturer Narrative
H6.Investigation summary: according to the evidence received showing the lack of label in the base and within the report mentioning that one product had no product information label affixed to the base.We can identify this issue as a failure mode related to the manufacturing process due to process omission at the time to perform the relabeling process.For this reason, quality alert was posted to the personnel involved.The current controls within the process were reviewed and it was found that improvement actions have been implemented which consists in an installation of a vision system and rework stations in order to prevent, reinforce and make more robust the labeling processes, these actions are documented in a capa.Since no lot number was provided we can¿t confirm if this product was manufactured before or after these implementations were completed.A review of customer complaint records was performed; in accordance with the cc¿s records, four additional complaints were received throughout the last twelve months for the same part number and issue in which it was confirmed the issue as related to the manufacturing process.
Event or Problem Description
It was reported that the bd¿ multi-use nestable sharps collector had no label on it.The following information was provided by the initial reporter, translated from japanese: "this is a report about a missing label of sharps collector.During the inspection of products after unpacking at the customer's side, no label was affixed to one of 24 products.".

• Brand Name: BD¿ MULTI-USE NESTABLE 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: 15848097
• Report Number: 2243072-2022-02031
• Device Sequence Number: 5116235
• Product Code: FMI
• UDI-Device Identifier: 00382903053438
• UDI-Public: (01)00382903053438
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943134
• 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): 11/30/2022

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 Catalogue Number: 305343
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/08/2022
• 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