MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER SST BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367981
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported the bd vacutainer® sst¿ blood collection tubes experienced under-fill, or low draw of a tube with blood.The following information was provided by the initial reporter: the customer experienced under filling when using vacutainers.The customer complained of having low vacuum issue with bd vacutainer sst tube.
Event or Problem Description
It was reported the bd vacutainer® sst¿ blood collection tubes experienced under-fill or low draw of a tube with blood.The following information was provided by the initial reporter: the customer experienced under filling when using vacutainers.The customer complained of having low vacuum issue with bd vacutainer sst tube.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer for evaluation.Therefore, 20 retention samples from bd inventory were evaluated by functional testing and the issue relating to underfill was observed.We are reviewing specific areas in the manufacturing process where the cause of this issue may have originated to identify improvements that will help reduce the occurrence of underfill.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.

• Brand Name: BD VACUTAINER SST BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 10886815
• Report Number: 1024879-2020-00873
• Device Sequence Number: 14259823
• Product Code: JKA
• UDI-Device Identifier: 50382903679817
• UDI-Public: 50382903679817
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• 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): 12/14/2020

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: 04/30/2021
• Device Model Number: 367981
• Device Catalogue Number: 367981
• Device Lot Number: 0122306
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1