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

Model 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	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during use with bd microtainer® sst¿ out of 4 samples had no serum obtained after centrifugation.The patient was re-collected.The following information was provided by the initial reporter: this is the 4th of 5 occurrences.It was reported by the customer no serum obtained after centrifugation we tried spinning using the horizontal swing bucket instead of the fixed angled, same outcome on 10% of the samples.We are suspecting perhaps these specimens might have been grossly hemolyzed such that it affects the density and thus the gel separation.· did the specimen(s) need to be recollected? yes.· did exposure to blood/ bf occur? no.
Event or Problem Description
It was reported that during use with bd microtainer® sst¿ out of 4 samples had no serum obtained after centrifugation.The patient was re-collected.The following information was provided by the initial reporter: this is the 4th of 5 occurrences.It was reported by the customer no serum obtained after centrifugation we tried spinning using the horizontal swing bucket instead of the fixed angled, same outcome on 10% of the samples.We are suspecting perhaps these specimens might have been grossly hemolyzed such that it affects the density and thus the gel separation.· did the specimen(s) need to be recollected? yes.· did exposure to blood/ bf occur? no.
Additional Manufacturer Narrative
H.6 investigation summary material #: 365967.Lot/batch #: 2124289.Bd had not received samples, but 5 photos were provided for investigation.The photos were reviewed and the indicated failure mode for poor barrier separation was observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, the indicated failure mode for poor barrier separation was not observed.Bd was unable to duplicate the customer¿s indicated failure mode, poor barrier separation, because the defect was not evident in the testing of the complaint lot samples.Visual evaluations of both retention and control samples demonstrated clinically acceptable performance for all visual observations evaluated.Laboratory evaluation of samples indicated that these tubes performed as expected.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 poor barrier separation based on photos only.Bd was not able to identify a root cause for the indicated failure mode.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 MICROTAINER® SST¿
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16244222
• Report Number: 2618282-2023-00008
• Device Sequence Number: 15108980
• Product Code: JKA
• UDI-Device Identifier: 50382903659673
• UDI-Public: (01)50382903659673
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/28/2023

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: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 365967
• Device Catalogue Number: 365967
• Device Lot Number: 2124289
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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