MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) PAXGENE® BLOOD DNA TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	761165
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	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported after use the paxgene® blood dna tube had erroneous results.The following information was provided by the initial reporter: "the blood is fractionation, customer inverts 10 time after collection and then lets it sit for 72 hour then inverts the blood 8-10 time before freezing.¿.
Event or Problem Description
It was reported after use the paxgene® blood dna tube had erroneous results.The following information was provided by the initial reporter: "the blood is fractionation, customer inverts 10 time after collection and then lets it sit for 72 hour then inverts the blood 8-10 time before freezing.¿.
Additional Manufacturer Narrative
H.6.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 manufacturing records could not be conducted.H3 other text : see section h.10.

• Brand Name: PAXGENE® BLOOD DNA TUBE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 9837186
• Report Number: 9617032-2020-00249
• Device Sequence Number: 16926758
• Product Code: PJE
• UDI-Device Identifier: 54053727611654
• UDI-Public: 54053727611654
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K142821
• 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): 03/18/2020

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 Model Number: 761165
• Device Catalogue Number: 761165
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 03/18/2020
• 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