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

Model Number	367294
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd vacutainer® safety-lok¿ blood collection set experienced blood leakage.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: blood leakage inside the collection adaptor (customer uses tubes from greiner and bd's perforation devices).
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) an oem manufacturing site.Medical device expiration date: unknown.Initial reporter phone #: (b)(6).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 that the bd vacutainer® safety-lok¿ blood collection set experienced blood leakage.There was no report of patient impact.The following information was provided by the initial reporter, translated from portuguese to english: blood leakage inside the collection adaptor (customer uses tubes from greiner and bd's perforation devices).
Additional Manufacturer Narrative
H6: investigation summary bd had not received samples, but 4 photos were provided by the customer for investigation.The photos were reviewed and the indicated failure mode for leakage was observed.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.This complaint has been confirmed for the indicated failure mode leakage.Since the lot number is unknown and no samples are available, we were unable to perform investigation at this time.H3 other text : see h10.

• 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: 12918009
• Report Number: 2243072-2021-02842
• Device Sequence Number: 5271150
• Product Code: JKA
• UDI-Device Identifier: 50382903672948
• UDI-Public: 50382903672948
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2021

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: Health Professional
• Device Model Number: 367294
• Device Catalogue Number: 367294
• 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: 11/05/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/07/2022
• 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