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	368056
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
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 during use the bd vacutainer® pst¿ gel and lithium heparinn (lh) 65 units blood collection tubes experienced discolored/abnormal additive form.This event occurred 22 times.The following information was provided by the initial reporter: the customer stated "that twenty two samples were spun and the sample appeared cloudy.".
Event or Problem Description
It was reported during use the bd vacutainer® pst¿ gel and lithium heparinn (lh) 65 units blood collection tubes experienced discolored/abnormal additive form.This event occurred 22 times.The following information was provided by the initial reporter: the customer stated "that twenty two samples were spun and the sample appeared cloudy.".
Additional Manufacturer Narrative
H6: investigation summary: bd had not received samples or photos for evaluation.Therefore, 10 retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to poor plasma(hazy, lipemic) were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure (sample quality/cloudiness) because the defect was not evident in the testing of the customer lot samples.Replicates of both retain and control samples tested for applicable analytes were acceptable in terms of both precision and accuracy.All analytes demonstrated clinically acceptable performance for all visual observations evaluated.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.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
• 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: 10692081
• Report Number: 1917413-2020-00953
• Device Sequence Number: 3006593
• Product Code: JKA
• UDI-Device Identifier: 50382903680561
• UDI-Public: 50382903680561
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• 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): 03/18/2021

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 Expiration Date: 02/28/2021
• Device Model Number: 368056
• Device Catalogue Number: 367961
• Device Lot Number: 0044193
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 03/18/2021
• 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