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

Model Number	761165
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1210563.Medical device expiration date: 31-oct-2022.Device manufacture date: 29-jul-2021.Medical device lot #: 1246399.Medical device expiration date: 30-nov-2022.Device manufacture date: 03-sep-2021.Medical device lot #: 2041397.Medical device expiration date: 30-apr-2023.Device manufacture date: 10-feb-2022.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 paxgene® blood dna tube there was missing additive.This event affected 103,550 devices.The following information was provided by the initial reporter.The customer stated: "the product is presenting low yield.Most samples failing dna extraction qc are failing concentration.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 2022-09-22.H.6.Investigation summary: bd received 10 samples from each lot.Unfortunately, there is no testing that can be done for low yield.Our ifu (instructions for use) does not provide for any specific yield claims.Yields depend on the patient, the quality of the specimen, and the method used for isolation.A complaint history review was conducted and only the current complaint was found relating to the incident lot numbers: 1210563, 1246399, 2041397 the ¿as reported¿ defect code.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.This complaint is unable to be confirmed low yield.Bd was not able to identify a root cause for the indicated failure mode.A review of our ifu is recommended.
Event or Problem Description
It was reported when using the paxgene® blood dna tube there was missing additive.This event affected (b)(4) devices.The following information was provided by the initial reporter.The customer stated: "the product is presenting low yield.Most samples failing dna extraction qc are failing concentration.".

• 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
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15421875
• Report Number: 9617032-2022-00879
• Device Sequence Number: 12416844
• Product Code: PJE
• UDI-Device Identifier: 54053727611654
• UDI-Public: 54053727611654
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142821
• 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): 10/24/2022

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: 761165
• Device Catalogue Number: 761165
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown