MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER TUBES WITH LH (LITHIUM HEPARIN); BLOOD SPECIMEN COLLECTION DEVICE

Model Number	365965
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field."multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 925441n, medical device expiration date: 2021-02-28, device manufacture date: 2019-09-11, medical device lot #: 927410n, medical device expiration date: 2021-03-31, device manufacture date: 2019-10-01." a sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that during use samples are hemolyzed with a bd microtainer® tubes with lh (lithium heparin).The following information was provided by the initial reporter: reported experiencing hemolyzed specimens when using lots 925441n and 927410n.This started occurring within the last 3 months, no specific amount of specimens affected.Customer states there are no reports of erroneous results as they are the drawing lab.No reports from testing lab of erroneous results.She will be conducting draws today so photos may be available after today.Though she did confirm unused tubes are available for investigation now.
Additional Manufacturer Narrative
H.6.Investigation: this complaint is for hemolyzed specimens observed while using next generation microtainer tubes with lithium heparin additive- material number: 365965, lot: 925441n and 927410n.Ten unused samples were received for further analysis if required.In addition 50 retention samples from each lot were visually observed with acceptable results.Per complaint history check this is the first complaint reported for the same defect/condition for lot 925441n and 927410n.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.The product circular (vdp40084) which contain the instruction for use (ifu) was reviewed.It was noted that the time frame for specimen analysis is defined; the correct specimen collection techniques is defined which clearly states that "milking" of skin puncture site may cause hemolysis; clear mixing instructions are provided (invert tube 8-10 times to assure anticoagulation) and centrifugation instructions are defined.Based on the investigation results to date, defect was not confirmed.Factors related to the user handling or patient conditions cannot be discarded as possible root causes.Retention samples were visually evaluated with acceptable results.No further actions are not required at this time.Technical service did reach out and provided additional educational material.
Event or Problem Description
It was reported that during use samples are hemolyzed with a bd microtainer® tubes with lh (lithium heparin).The following information was provided by the initial reporter: reported experiencing hemolyzed specimens when using lots 925441n and 927410n.This started occurring within the last 3 months, no specific amount of specimens affected.Customer states there are no reports of erroneous results as they are the drawing lab.No reports from testing lab of erroneous results.She will be conducting draws today so photos may be available after today.Though she did confirm unused tubes are available for investigation now.

• Brand Name: BD MICROTAINER TUBES WITH LH (LITHIUM HEPARIN)
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 10179775
• Report Number: 2618282-2020-00054
• Device Sequence Number: 14207405
• Product Code: JKA
• UDI-Device Identifier: 50382903659659
• UDI-Public: 50382903659659
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K991702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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 Model Number: 365965
• Device Catalogue Number: 365965
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other