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

Model Number	367297
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd vacutainer® safety-lok¿ blood collection set, the device experienced blood splatter/ leakage from the device.The following information was provided by the initial reporter.The customer stated: it was reported that blood was spilling out of the tube all the way to transferring to the vacutatiner.Customer is asking if we have end to end instructions on how to keep blood from spilling out of tube all the way to transferring to the vacutatiner.
Event or Problem Description
It was reported when using the bd vacutainer® safety-lok¿ blood collection set, the device experienced blood splatter/ leakage from the device.The following information was provided by the initial reporter.The customer stated: it was reported that blood was spilling out of the tube all the way to transferring to the vacutatiner.Customer is asking if we have end to end instructions on how to keep blood from spilling out of tube all the way to transferring to the vacutatiner.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.According to the shipping record, a total of 135 lots were manufactured under material # 367297 for the past 3 years (b)(6) 2019 to (b)(6) 2021.3 lots (9h2281, 0f3081, and 1g2081) were chosen as representative lots.Our retained samples of the above 3 lots were checked visually and no abnormalities such as damage or molding defect was found in the routes.Next, water sampling test was performed, water could be sampled normally without any leakage from the route, connection, or blood tube.The shipping inspection record of 65 lots which were manufactured under material # 367297 from (b)(6) 2020 to (b)(6) 2021 were reviewed and no abnormalities were found.This complaint is unable to be confirmed.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): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12789880
• Report Number: 2243072-2021-02700
• Device Sequence Number: 17413749
• Product Code: JKA
• UDI-Device Identifier: 50382903672979
• UDI-Public: 50382903672979
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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: 367297
• Device Catalogue Number: 367297
• 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: 10/14/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 01/19/2022
• 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