MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR 8 QT MULTI-USE NESTABLE; 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	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).
Event or Problem Description
It was reported that 2 bd sharps collectors 8 qt multi-use nestable had missing biohazard warning labels.The following information was provided by the initial reporter: this is a report about missing labels of sharps collector.According to the customer's report, the biohazard warning label was missing.
Event or Problem Description
It was reported that 2 bd sharps collectors 8 qt multi-use nestable had missing biohazard warning labels.The following information was provided by the initial reporter: this is a report about missing labels of sharps collector.According to the customer's report, the biohazard warning label was missing.
Additional Manufacturer Narrative
H6: investigation summary: a device history review could not be completed as no batch number was provided.Based on this investigation, there was no evidence received showing the lack of label in the base, however, in the report it¿s mentioned that biohazard warning label was missing.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.Since no lot number was provided, it can¿t be confirmed if this product was manufactured before or after the corrective action¿s implementation.Based on this investigation and information provided as evidence, it was confirmed this issue was related to manufacturing process.

• Brand Name: BD SHARPS COLLECTOR 8 QT MULTI-USE 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: 15183080
• Report Number: 2243072-2022-01232
• Device Sequence Number: 6612898
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: UNKNOWN
• 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: 08/19/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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