MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367960

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Date 03/02/2020

Event Type  malfunction  

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 Description

It was reported after use the bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tubes had poor barrier separation of sample.The following information was provided by the initial reporter: the tube separates the cells from plasma and sits between plasma and cells.In this situation the gel is on top of the plasma blocking it.The probe in chemistry analyzer sucks the gel and gets blocked - needing for a replacement of probe and redraw of patient.".

Manufacturer Narrative

H.6.Investigation: bd received samples and photos from the customer facility for investigation.The investigation consisted of an evaluation of the photos provided, device history record review, and a review of the complaint information provided.Upon evaluation of the customer¿s photo that was returned from customer facility, showed the defect as ¿poor barrier separation¿.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.The complaint was evaluated to determine if further testing was necessary on the returned products.The centrifugation conditions described by the customer are inadequate for proper barrier formation.A review of specimen handling parameters should be reviewed for this tube type.To assure a high quality specimen when utilizing heparin plasma, several factors are key.Included, but not limited to this are: proper phlebotomy technique to minimize hemolysis and platelet activation, proper tube fill volume to assure the proper blood-to-additive ration, gentle and thorough mixing, proper centrifugation conditions-g force and time, and storage conditions.Although heparin plasma is the specimen of choice in many laboratories, it represents a more complex specimen than serum.Adhering to the recommended specimen handling and processing steps will facilitate acceptable specimen quality and overall performance for reliable analytical outcomes.Bd is continually monitoring complaints received for this device and reported condition in order to identify emerging trends.H3 other text : see h.10.

Event Description

It was reported after use the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes had poor barrier separation of sample.The following information was provided by the initial reporter: the tube separates the cells from plasma and sits between plasma and cells.In this situation the gel is on top of the plasma blocking it.The probe in chemistry analyzer sucks the gel and gets blocked - needing for a replacement of probe and redraw of patient.".

• Brand Name: BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 9866889
• MDR Text Key: 186704032
• Report Number: 1917413-2020-00317
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679602
• UDI-Public: 50382903679602
• Combination Product (y/n): N
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Model Number: 367960
• Device Catalogue Number: 367960
• Device Lot Number: 9344001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other