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

Catalog Number	761165
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: 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 that paxgene® blood dna tube was experiencing low draw.This occurred on 2 occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: material no: 761165, batch no: 8164968 it was reported the tube is not working as the vacuum seal created between the tube and the vacutainer appears to be very weak.The lot number for both the opened, dysfunctional tubes, and the unopened tube package that we have is the same.It is 8164968.This implies to me that the unopened package would not work either.The tube is not working for us as the vacuum seal created between the tube and the vacutainer appears to be very weak.This is causing little to no blood flow into the tube and preventing us from collecting this sample type.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to underfill as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Based on evaluation of the retain samples, the customer¿s indicated failure mode for underfill with the incident lot was not observed as all samples met the required specifications.Based on the investigation, a root cause could not be determined.The retain product was found to be in conformance and meet release specifications.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 paxgene® blood dna tube was experiencing low draw.This occurred on 2 occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: material no: 761165 batch no: 8164968.It was reported the tube is not working as the vacuum seal created between the tube and the vacutainer appears to be very weak.The lot number for both the opened, dysfunctional tubes, and the unopened tube package that we have is the same.It is 8164968.This implies to me that the unopened package would not work either.The tube is not working for us as the vacuum seal created between the tube and the vacutainer appears to be very weak.This is causing little to no blood flow into the tube and preventing us from collecting this sample type.

• 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
• MDR Report Key: 8663069
• Report Number: 9617032-2019-00640
• Device Sequence Number: 14017422
• Product Code: PJE
• UDI-Device Identifier: 54053727611654
• UDI-Public: 54053727611654
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/28/2019

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 Expiration Date: 06/30/2019
• Device Catalogue Number: 761165
• Device Lot Number: 8164968
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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