MAUDE Adverse Event Report: BD DISTRIBUTION CENTER BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367297
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fda notified? the initial reporter also notified the fda on (b)(6) 2022 via medwatch # mw5111103.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 bd vacutainer® safety-lok¿ blood collection set safety lok does not have proper closure.The following information was provided by the initial reporter: "the bd vacutainer safety-lok feature does not close properly.Fda safety report id#: (b)(4).".
Event or Problem Description
It was reported that bd vacutainer® safety-lok¿ blood collection set safety lok does not have proper closure.The following information was provided by the initial reporter: "the bd vacutainer safety-lok feature does not close properly.Fda safety report id# (b)(4).".
Additional Manufacturer Narrative
H.6.Investigation summary: material # 367297.Lot/batch # 1m0681.Bd had not received samples or photos for investigation.Therefore, 50 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to does not close properly as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode does not close properly.Bd was not able to identify a root cause for the indicated failure mode.As described above, since no abnormalities were found from the retained samples, manufacturing record and inspection record, it was considered the product had no defects.Under our manufacturing process, molding parts like safety shields and winged hubs are inspected per molding lot and only conforming parts are used for the product assembly.In addition, appearance and function are inspected at process inspection and release inspection per product lot.Therefore, the possibility that a product with a defect from the beginning is generated and shipped out is very low.As stated in the ifu, please hold the end of safety shield and tubing, and slide the safety shield straight to cover the winged needle without holding the wings.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD DISTRIBUTION CENTER; 2200 west san bernardino ave; redlands CA 92374
• Manufacturer (Section G): BD DISTRIBUTION CENTER; 2200 west san bernardino ave; redlands CA 92374
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15246230
• Report Number: 3005503186-2022-00001
• Device Sequence Number: 5807958
• Product Code: JKA
• UDI-Device Identifier: 50382903672979
• UDI-Public: 50382903672979
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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 Expiration Date: 12/31/2024
• Device Model Number: 367297
• Device Catalogue Number: 367297
• Device Lot Number: 1M0681
• 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: 08/09/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2022
• 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