MAUDE Adverse Event Report: BD CARIBE LTD. BD VACUTAINER® EDTA 2K LUER LOCK; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	364902
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® edta 2k luer lock there was blood spilled.The following information was provided by the initial reporter.The customer stated: "the customer complained that there was blood spillage during sampling at the connecting part of the needle and holder inside the luer-lok access device".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 3 samples and 3 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for sleeve leakage was observed.The customer samples were evaluated by visual examination functional testing and the indicated failure mode for leakage with the incident lot was not observed.Additionally, 48 retention samples from bd inventory were evaluated by visual examination and another 12 retention samples by functional testing and the issue of leakage was not observed.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.The following fields were updated due to additional information: d9: device available for evaluation:  yes.D9: returned to manufacturer on: 2023-07-25.
Event or Problem Description
It was reported when using the bd vacutainer® edta 2k luer lock there was blood spilled.The following information was provided by the initial reporter.The customer stated: "the customer complained that there was blood spillage during sampling at the connecting part of the needle and holder inside the luer-lok access device.".

• Brand Name: BD VACUTAINER® EDTA 2K LUER LOCK
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17213184
• Report Number: 2618282-2023-00050
• Device Sequence Number: 15228340
• Product Code: JKA
• UDI-Device Identifier: 50382903649025
• UDI-Public: 50382903649025
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K991088
• 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): 08/07/2023

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 Expiration Date: 05/31/2025
• Device Model Number: 364902
• Device Catalogue Number: 36490200
• Device Lot Number: 2140913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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