MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG; BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING

Model Number	362799
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg were missing vacuum and not filling properly.The following information was provided by the initial reporter: in 14 of 7600 tubes used so far, there have been problems with the blood collection (missing vacuum).The tubes were not filled properly and therefore cannot be used for molecular virus detection of the blood donation.
Additional Manufacturer Narrative
E.3.Initial reporter phone (b)(6).H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to underfill as all samples met specifications.10 production lot in-house retention tubes were inspected with 0 visible defects.A draw test was performed at the manufacturing site on the 10-production lot in-house retention tubes.All tubes were within specification limits.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.This complaint is unable to be confirmed for the indicated failure mode underfill.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples, but five (5) photos were provided for investigation.The photos were reviewed and the indicated failure mode for underfill was observed.Although this product does not have a fill line per specifications the amount of specimen in the tube is lower than expected for this product.Ten (10) retention samples from bd inventory were evaluated by functional testing and the issue of underfill was not observed.Additionally, one hundred (100) retention samples from bd inventory were visually examined and no defects were 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.This complaint has been confirmed for the indicated failure mode of underfill based on photo analysis.
Event or Problem Description
It was reported that the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg were missing vacuum and not filling properly.The following information was provided by the initial reporter: in 14 of 7600 tubes used so far, there have been problems with the blood collection (missing vacuum).The tubes were not filled properly and therefore cannot be used for molecular virus detection of the blood donation.

• Brand Name: BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG
• Common Device Name: BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17218778
• Report Number: 1917413-2023-00613
• Device Sequence Number: 3011017
• Product Code: PJE
• UDI-Device Identifier: 50382903627993
• UDI-Public: (01)50382903627993
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K972075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 08/31/2023
• Device Model Number: 362799
• Device Catalogue Number: 362799
• Device Lot Number: 2227088
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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