MAUDE Adverse Event Report: BECTON DICKINSON BD MULTI-PURPOSE SHARPS CONTAINER NESTABLE; 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	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd multi-purpose sharps container nestable was missing label.The following information was provided by the initial reporter: this is a report about a missing label of sharps collector.According to the customer's report, there was no label affixed to the base for one product.
Additional Manufacturer Narrative
Device expiration date: na.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.The manufacturing location for this product is flextronics.This site is an oem manufacturing site.(b)(4).
Event or Problem Description
It was reported that the bd multi-purpose sharps container nestable was missing label.The following information was provided by the initial reporter: this is a report about a missing label of sharps collector.According to the customer's report, there was no label affixed to the base for one product.
Additional Manufacturer Narrative
H6: investigation summary according to the dhr review process, the result showed there were no issues reported as missing label during the manufacturing process for the lot number reported (1307948).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.The actual sample is unavailable for investigation.Photos are provided for verification.According to the evidence received showing the lack of label in the base and within the report mentioning that one product had no product 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.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.The current manufacturing process was reviewed and it was found as capable of detecting missing label and that improvement actions have been implemented within the process and documented under the capa.However, based on the lot number provided, it¿s confirmed that this product was manufactured before these implementations (november 3, 2022).Quality alert was posted within the process in order to make aware all the people involved in the manufacturing process of this product.All the complaint information was also captured for tracking and trending purposes.H3 other text : see h10.

• Brand Name: BD MULTI-PURPOSE SHARPS CONTAINER NESTABLE
• 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: 15999835
• Report Number: 2243072-2022-02171
• Device Sequence Number: 6655852
• 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): 01/06/2023

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: 305343
• Device Lot Number: 1307948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2021
• 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