MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD SUREPREP¿ CAPILLARY TUBES- PLAIN; TUBE, COLLECTION, CAPILLARY BLOOD

Model Number	420315
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In this mdr, becton, dickinson & co.In (b)(4) has been listed as safe-tec clinical products llc is an oem manufacturing site.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 while using bd sureprep¿ capillary tubes- plain the customer observed leakage from tubes after centrifugation.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "customer reports 20-50% leakage on centrifugation from the ¿sealed¿ end of the capillary tube.".
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information: b.5.Additional information indicates that the event occurred 3 times.
Event or Problem Description
It was reported that while using bd sureprep¿ capillary tubes- plain the customer observed leakage from tubes after centrifugation.This event occurred 3 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "customer reports 20-50% leakage on centrifugation from the ¿sealed¿ end of the capillary tube." "did they try using a different centrifuge and did it work? yes.Same issues 2 other centrifuges.".
Additional Manufacturer Narrative
H.6.Investigation summary the customer complaint on product 420315, lot 110521, was not confirmed.The customer reported that their plain sureprep capillary tubes (cat.420315, lot 110521) had a 20-50% leakage on centrifugation from the ¿sealed¿ end of the capillary tube.An investigation of the retain samples and the device history record did not show any defects.A review of the returned samples revealed no defects.A review of past complaints for this product does not indicate a trend for this issue.No further action will be taken as this is an isolated incident.Bd quality assurance will continue to monitor for trending.H3 other text : see h.10.
Event or Problem Description
It was reported that while using bd sureprep¿ capillary tubes- plain the customer observed leakage from tubes after centrifugation.This event occurred 3 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "customer reports 20-50% leakage on centrifugation from the ¿sealed¿ end of the capillary tube." "did they try using a different centrifuge and did it work? yes.Same issues 2 other centrifuges.".

• Brand Name: BD SUREPREP¿ CAPILLARY TUBES- PLAIN
• Common Device Name: TUBE, COLLECTION, CAPILLARY BLOOD
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14458891
• Report Number: 1119779-2022-00726
• Device Sequence Number: 11888843
• Product Code: GIO
• UDI-Device Identifier: 30382904203154
• UDI-Public: 30382904203154
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K884623
• 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,Followup
• Report Date (Section B): 08/30/2022

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: 11/05/2023
• Device Model Number: 420315
• Device Catalogue Number: 420315
• Device Lot Number: 110521
• 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: 04/21/2022
• Supplement Date Received by Manufacturer: 05/17/2022; 08/30/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 05/24/2022; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• 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