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

Model Number	761165
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using paxgene® blood dna tube draw volume is very short.This event occurred 48 times.The following information was provided by the initial reporter: customer alleges that for product cat no 761165 the draw volume is very short.
Event or Problem Description
It was reported while using paxgene® blood dna tube draw volume is very short.This event occurred 7 times.The following information was provided by the initial reporter: customer alleges that for product cat no 761165 the draw volume is very short.
Additional Manufacturer Narrative
H6: investigation summary bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for underfill was observed.Additionally, 20 retention samples from bd inventory were evaluated by functional testing and the issue of underfill was not observed.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 able to confirm customers indicated failure mode of underfill based on the photographs provided, however retained samples test results were satisfactory.Bd was not able to identify a root cause for the indicated failure mode.

• 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: 14962356
• Report Number: 9617032-2022-00631
• Device Sequence Number: 15179627
• Product Code: PJE
• UDI-Device Identifier: 54053727611654
• UDI-Public: 54053727611654
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/13/2022

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 Expiration Date: 08/31/2022
• Device Model Number: 761165
• Device Catalogue Number: 761165
• Device Lot Number: 1167487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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