MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367961
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.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 that a bd vacutainer® pst¿ gel and lithium heparin (lh) 65 units blood collection tubes had hemolysis.The following was reported, 'it was reported the customer experienced hemolysis problems intermittently.Over the years, i have encountered hemolysis problems intermittently, and rarely, even after education, a tech may still have a high hemolysis rate on chemistry tubes.We note it most there because of analytes highly sensitive to hemolysis such as k+, mg+, ast, alt, ldh and a few others.From 2008 to 2012, the hemolysis index given by the machines was accurate and could be verified by other methodology.Not so much now.Please tell me what the vacuum pressure is for each of the following tubes:".
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Bd has followed up with the customer to provide troubleshooting.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that a bd vacutainer® pst¿ gel and lithium heparinn (lh) 65 units blood collection tubes had hemolysis.The following was reported, "it was reported the customer experienced hemolysis problems intermittently.Over the years, i have encountered hemolysis problems intermittently, and rarely, even after education, a tech may still have a high hemolysis rate on chemistry tubes.We note it most there because of analytes highly sensitive to hemolysis such as k+, mg+, ast, alt, ldh and a few others.From 2008 to 2012, the hemolysis index given by the machines was accurate and could be verified by other methodology.Not so much now.Please tell me what the vacuum pressure is for each of the following tubes:".

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8400279
• Report Number: 1917413-2019-00945
• Device Sequence Number: 13520265
• Product Code: JKA
• UDI-Device Identifier: 50382903680561
• UDI-Public: 50382903680561
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (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): 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 367961
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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