MAUDE Adverse Event Report: BECTON DICKINSON 5.4 QT BD¿ NEXT GENERATION PATIENT COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305517
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 8 5.4 qt bd¿ next generation patient collector had no label on the base.The following information was provided by the initial reporter: this is a report about a missing label of sharps collector.During the inspection at the distributor's side before delivery to a customer, it was found that there was no label onto the base.
Additional Manufacturer Narrative
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 (b)(4).This site is an oem manufacturing site.(b)(4).Medical device expiration date: na.
Additional Manufacturer Narrative
H.6.Investigation summary: based on this investigation, there was no evidence received showing the lack of label reported, however, within the issue description it¿s mentioned that during the inspection at the distributor¿s side before delivery to a customer, it was found that there was no label onto the base, also, with the lot number provided (1317906) we were able to confirm this product was manufactured by flex on november, 2021.With this information, we can identify this issue as a failure mode related to the manufacturing process.Due to this failure mode had already been detected within internal non-conformances for similar processes, improvement opportunities were identified to reinforce and make more robust the labeling processes which are documented in the capa record car-jrz-00000392 and par-jrz-00000170.
Event or Problem Description
It was reported that the 8 5.4 qt bd¿ next generation patient collector had no label on the base.The following information was provided by the initial reporter: this is a report about a missing label of sharps collector.During the inspection at the distributor's side before delivery to a customer, it was found that there was no label onto the base.

• Brand Name: 5.4 QT BD¿ NEXT GENERATION PATIENT 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: 15183089
• Report Number: 2243072-2022-01233
• Device Sequence Number: 17727672
• Product Code: FMI
• UDI-Device Identifier: 00382903055173
• UDI-Public: 00382903055173
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• 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): 08/18/2022

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: 305517
• Device Catalogue Number: 305517
• Device Lot Number: 1317906
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2021
• 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