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	05/26/2020
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.(b)(4).
Event or Problem Description
It was reported that 6 bd microtainer® tubes with lh (lithium heparin) were believed to be sodium lithium tubes and used for cytogenetic testing, where they were rejected by the clinic for "lithium us cytotoxic".The issue was discovered after use.The following information was provided by the initial reporter: stated the 6 green top microtainers had been drawn at the next-door children's hospital and sent to the clinic for genetic testing, only to be told they were unacceptable b/c lithium us cytotoxic.I told him sodium heparin microtainers are not available at this time, and we have no data supporting the use of lithium heparin for cytogenetic testing.I told him a 2.0 ml vacutainer is available with sodium heparin, and may be used when venous blood is drawn from neonates, typically from central lines.
Event or Problem Description
It was reported that 6 bd microtainer® tubes with lh (lithium heparin) were believed to be sodium lithium tubes and used for cytogenetic testing, where they were rejected by the clinic for "lithium us cytotoxic".The issue was discovered after use.The following information was provided by the initial reporter: stated the 6 green top microtainers had been drawn at the next-door children's hospital and sent to the clinic for genetic testing, only to be told they were unacceptable b/c lithium us cytotoxic.I told him sodium heparin microtainers are not available at this time, and we have no data supporting the use of lithium heparin for cytogenetic testing.I told him a 2.0 ml vacutainer is available with sodium heparin, and may be used when venous blood is drawn from neonates, typically from central lines.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer for investigation.Therefore, 50 retention samples from bd inventory were evaluated by visual examination.Retention samples were visually evaluated for correct caps with acceptable results.Per complaint history check this is the first complaint reported for the same defect/condition for lot 912391n.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 non-conformances during manufacturing of the product.The product circular (vdp40084) which contain the instruction for use (ifu) was reviewed.It was noted that the additive that is used in microtainer plasma tubes using green and mint green caps is lithium heparin.Packaging components like the polybag, shelf label and case label also clearly state that the additive used for this product is lithium heparin.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 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: 10164857
• Report Number: 2618282-2020-00048
• Device Sequence Number: 3513994
• Product Code: JKA
• UDI-Device Identifier: 50382903659659
• UDI-Public: 50382903659659
• 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
• 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): 07/07/2020

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 Expiration Date: 10/31/2020
• Device Model Number: 365965
• Device Catalogue Number: 365965
• Device Lot Number: 912391N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/07/2020
• 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