MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER.

Model Number	362725
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	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: unknown.Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for low draw volume with the incident lot was not observed.Additionally, retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to low draw volume 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-conformance's during manufacturing of the product.
Event or Problem Description
It was reported that tubes are under filling during use with a bd vacutainer® est z (no additive) plus blood collection tubes.The following information was provided by the initial reporter, translated from (b)(6) to english: after the procedure, my colleague did not fill in any plasma in the transparent and yellow tubes.I tried with a new yellow tube myself and only filled in a little plasma.

• Brand Name: BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER.
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 9910316
• Report Number: 9617032-2020-00306
• Device Sequence Number: 14390864
• Product Code: FMH
• UDI-Device Identifier: 50382903627252
• UDI-Public: 50382903627252
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2020

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 Expiration Date: 05/31/2021
• Device Model Number: 362725
• Device Catalogue Number: 362725
• Device Lot Number: 9329088
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/01/2020
• 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