MAUDE Adverse Event Report: BD CARIBE LTD. TUBE MICRO W/MICROGARD PLN RD; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	365963
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported when using the tube micro w/microgard pln rd there was missing additive.The following information was provided by the initial reporter: translated to english.The customer stated: "we have been facing troubles with the no additive tube w/microgard color red stopper.The issue it presents is that the sample, after being centrifuged, suffers hemolysis.According to customer, it has been discarded if it could has been caused by the sample taking, the rotation, and the time in centrifuge, nor an improper handling of the sample.Customer concluded that the issue regards the tube.".
Additional Manufacturer Narrative
H6: investigation summary: bd had not received samples, but 2 photos and 1 video were provided for investigation.The photos and video were reviewed and the indicated failure mode for hemolysis was observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to hemolysis were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate the customer¿s indicated failure, because the defect was not evident in the testing of the complaint lot samples.Visual evaluations of both complaint lot (retains) and control samples demonstrated clinically acceptable performance for all visual observations evaluated.Laboratory analysis 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 based on the photos and video provided, all other testing and analysis was satisfactory.H3 other text : see h10.
Event or Problem Description
It was reported when using the tube micro w/microgard pln rd there was missing additive.The following information was provided by the initial reporter: translated to english.The customer stated: "we have been facing troubles with the no additive tube w/microgard color red stopper.The issue it presents is that the sample, after being centrifuged, suffers hemolysis.According to customer, it has been discarded if it could has been caused by the sample taking, the rotation, and the time in centrifuge, nor an improper handling of the sample.Customer concluded that the issue regards the tube.".

• Brand Name: TUBE MICRO W/MICROGARD PLN RD
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 11314594
• Report Number: 2618282-2021-00011
• Device Sequence Number: 11685515
• Product Code: JKA
• UDI-Device Identifier: 50382903659635
• UDI-Public: 50382903659635
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 08/31/2021
• Device Model Number: 365963
• Device Catalogue Number: 365963
• Device Lot Number: 0057270
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1