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

Model Number	305343
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
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: "the customer's verbatim report is that there was no product label sticker affixed to the side surface of one base.".
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).Medical device expiration date: na.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.
Additional Manufacturer Narrative
H6: investigation summary based on this investigation, there is not enough information provided showing the lack of label, however with lot number provided under this complaint, we are able to confirm that this product was manufactured by flex on (b)(6) 2021 and within the report description, mentioning that there was no product label sticker affixed to the side surface of one base, we can identify this issue as a failure mode related to the manufacturing process due to process omission.For this reason, quality alert was posted to aware the personnel involved.The current controls within the process were reviewed and it was found that this characteristic is visually inspected by production department as well that during a second inspection based on an aql sampling plan performed by quality inspector; however, the probability to omit it by error could happened.A review of customer complaint records was performed; in accordance with the cc¿s records, two 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.H3 other text : see h.10.
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: "the customer's verbatim report is that there was no product label sticker affixed to the side surface of one base.".

• 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: 15481572
• Report Number: 2243072-2022-01625
• Device Sequence Number: 12500783
• Product Code: FMI
• UDI-Device Identifier: 50382903053433
• UDI-Public: (01)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): 10/03/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 10/14/2022
• 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): 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