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

Catalog Number	420317
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr ownership short description: no exact event type is available for bd sureprep¿ capillary tubes leaking patient sample, therefore, leaking/broken bactec bottle - containing patient sample has been used for reportability purposes.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd sureprep¿ capillary tubes- heparinized, blood is spilling out of two boxes of tubes.No patient impact reported.The following information was provided by the initial reporter: "customer is reporting blood is spilling out.How are the capillary tubes stored when not in use? tubes are stored at room temperature in its original packaging.How are the tubes being filled? filled with whole blood by retro orbital bleeds and saphenous vein.Once the tube is filled, how long is the blood remaining in contact with the self-sealing plug? once blood has reached the self-sealing plug.Then placed upright plug facing downwards.Quantity of two boxes affected.".
Additional Manufacturer Narrative
H.6.Investigation summary: complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: the review of the device history record did not indicate any manufacturing issues.Sample analysis: a review of the photos provided did not reveal any defect.An inspection of the retention samples was satisfactory.No defects were found.Evaluations results: based on the investigation, no defect was observed.No complaint trend has been observed.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed.No further actions will be taken as no confirmed trend has been identified.However, bd will continue to monitor for trending.H3 other text : see h10.
Event or Problem Description
It was reported that while using bd sureprep¿ capillary tubes- heparinized, blood is spilling out of two boxes of tubes.No patient impact reported.The following information was provided by the initial reporter: "customer is reporting blood is spilling out.How are the capillary tubes stored when not in use? tubes are stored at room temperature in its original packaging.How are the tubes being filled? filled with whole blood by retro orbital bleeds and saphenous vein.Once the tube is filled, how long is the blood remaining in contact with the self-sealing plug? once blood has reached the self-sealing plug.Then placed upright plug facing downwards.Quantity of two boxes affected.".

• Brand Name: BD SUREPREP¿ CAPILLARY TUBES- HEPARINIZED
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17845598
• Report Number: 1119779-2023-01036
• Device Sequence Number: 4387129
• Product Code: GIO
• UDI-Device Identifier: 30382904203178
• UDI-Public: 30382904203178
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/20/2023

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: 03/28/2025
• Device Catalogue Number: 420317
• Device Lot Number: 032823
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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