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

Model Number	365987
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd microtainer® pst¿ tubes with lh (lithium heparin), the device experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "is there only one size available for the microtainer tubes? the new chemistry analyzers use more plasma, and we are seeing a high number of qns draws on babies.They have been trying to draw 2 tubes, but the parents are getting angry.I am wondering if we can just get them a bigger tube to use and they won¿t have to fill the entire thing.".
Event or Problem Description
It was reported when using the bd microtainer® pst¿ tubes with lh (lithium heparin), the device experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "is there only one size available for the microtainer tubes? the new chemistry analyzers use more plasma, and we are seeing a high number of qns draws on babies.They have been trying to draw 2 tubes, but the parents are getting angry.I am wondering if we can just get them a bigger tube to use and they won¿t have to fill the entire thing.".
Additional Manufacturer Narrative
H.6.Investigation: bd did not receive samples or photographs from the customer in support of this complaint.Bd was unable to duplicate or confirm the customer¿s indicated failure mode.The device history records could not be reviewed because lot number was not provided.Root cause could not be determined.H3 other text : see h.10.

• Brand Name: BD MICROTAINER PST 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: 12350668
• Report Number: 2618282-2021-00051
• Device Sequence Number: 4115712
• Product Code: JKA
• UDI-Device Identifier: 50382903659871
• UDI-Public: 50382903659871
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 08/23/2021

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 Model Number: 365987
• Device Catalogue Number: 365987
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1