MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® SST¿; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	365967
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 2339674.D4.Medical device expiration date: 29feb2024.H4.Device manufacture date: 05dec2022.H3.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported by the customer that while using bd microtainer® sst¿ the samples are not clotting.The following information was provided by the customer: it was reported by the customer that samples are not clotting.Tubes will occasionally not clot after 30 min.Approximately 6 samples affected.
Event or Problem Description
It was reported by the customer that while using bd microtainer® sst¿ the samples are not clotting.The following information was provided by the customer: it was reported by the customer that samples are not clotting.Tubes will occasionally not clot after 30 min.Approximately 6 samples affected.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received customer returned samples for investigation.No photos were provided.Customer returned sample evaluation: five (5) samples from lot 3041654 were received.The tube printing of the five samples was blurry, and the lot number of one sample was not possible to identify but all cavity numbers were present.Five (5) samples from lot 2339674 were received.The tube printing of two samples were blurry, and the lot numbers and the cavity number were not possible to identify.Samples from both lots were visually inspected for presence of dry additive with acceptable results in both lots.Samples of each lot were tested at the juncos laboratory for additive concentration testing with acceptable results.Retention sample evaluation: manufacturer retained samples from 3041654 and 2339674 (fifty 50 per lot) were visually inspected for presence of dry additive with acceptable results on both lots.From these samples of each lot, fifteen (15) were tested at the juncos laboratory for additive concentration with acceptable results.Complaints for sample quality are under statistical control for the month of july 2023.At this time, further testing is not indicated.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 is unable to be confirmed for poor clot formation.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD MICROTAINER® SST¿
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17421815
• Report Number: 2618282-2023-00061
• Device Sequence Number: 6054720
• Product Code: JKA
• UDI-Device Identifier: 50382903659673
• UDI-Public: (01)50382903659673
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K991702
• 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): 08/15/2023

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: 02/29/2024
• Device Catalogue Number: 365967
• Device Lot Number: 2339674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 07/30/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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