MAUDE Adverse Event Report: BD CARIBE LTD. BD MINIDRAW¿ SST¿ CAPILLARY BLOOD COLLECTION TUBE; CAPILLARY BLOOD COLLECTION TUBE IVD

Catalog Number	366604
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd minidraw¿ sst¿ capillary blood collection tube there was an incorrect printed fill line on one device.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure mode for incorrect fill lines was observed.Additionally, 45 retention samples were evaluated by visual examination, and the issue of incorrect fill lines 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.This complaint has been confirmed for the indicated failure mode incorrect fill lines.Bd was not able to identify a root cause for the indicated failure mode.Based on the low defect rate for the batch in question, no actions are planned at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the bd minidraw¿ sst¿ capillary blood collection tube there was an incorrect printed fill line on one device.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported when using the bd minidraw¿ sst¿ capillary blood collection tube there was an incorrect printed fill line on one device.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 04-nov-2025.Investigation summary: bd received 3 photos and 5 representative customer samples for investigation.The photos were reviewed and the indicated failure mode for incorrect fill lines was observed, nevertheless the issue of incorrect fill lines was not observed in the customer samples provided.Additionally, 45 retention samples were evaluated by visual examination, and the issue of incorrect fill lines 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.This complaint has been confirmed for the indicated failure mode incorrect fill lines.Bd was not able to identify a root cause for the indicated failure mode.Based on the low defect rate for the batch in question, no actions are planned at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MINIDRAW¿ SST¿ CAPILLARY BLOOD COLLECTION TUBE
• Common Device Name: CAPILLARY BLOOD COLLECTION TUBE IVD
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23044312
• Report Number: 2618282-2025-00100
• Device Sequence Number: 9476796
• Product Code: JKA
• UDI-Device Identifier: 00382903666041
• UDI-Public: (01)00382903666041(17)260131(10)4222836
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230391
• 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): 11/07/2025

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: 01/31/2026
• Device Catalogue Number: 366604
• Device Lot Number: 4222836
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 11/07/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/30/2025; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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