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

Model Number	305343
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
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 manufacture: the manufacturing location for this product is sandoz.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.Device expiration date: na.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¿ multi-use nestable sharps collector experienced a missing biohazard label.The following information was provided by the initial reporter: this is a report about a missing label on sharps collector.One product had no label.
Event or Problem Description
It was reported that the bd¿ multi-use nestable sharps collector experienced a missing biohazard label.The following information was provided by the initial reporter: this is a report about a missing label on sharps collector.One product had no label.
Additional Manufacturer Narrative
H.6.Investigation summary: according to the dhr review process, the result showed there were no issues reported as missing label during the manufacturing process of the lot number (1297904) reported under this customer complaint.Also, a review of the ncmr¿s was performed; the result showed there was only one ncmr reported for the same issue and part number throughout the last twelve months.Based on this investigation and evidence provided such as lot number and description of the issue, we are able to confirm that this product was manufactured by flex on october 24, 2021 and within the report description, mentioning that one product had no label, 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 from previous complaint.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 , however, based on the lot number provided we can confirm that the product was manufactured before these implementations were completed.A review of customer complaint records was performed; in accordance with the cc¿s records, three 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.Root cause: reprocessing of material not followed properly.Omission error within the visual inspection.Containment action: quality alert was posted to aware personnel involved in the manufacturing process of this product.Conclusion: based on this investigation, it was determined that this failure mode is related to the manufacturing process since the lack of label would be an omission error during reprocessing material at the time to detect damaged label through the conveyor.

• 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: 15849696
• Report Number: 2243072-2022-02029
• Device Sequence Number: 12068613
• Product Code: FMI
• UDI-Device Identifier: 50382903053433
• UDI-Public: 50382903053433
• 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): 12/01/2022

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: 305343
• Device Catalogue Number: 305343
• Device Lot Number: 1297904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• 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: 12/01/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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