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	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that under filling is occurring during use with a bd vacutainer® sst¿ blood collection tubes.The following information was provided by the initial reporter: i work for a medical device company, and while collecting venipuncture blood for a research study, we have had multiple problems with one lot of bd sst-vacutainers.The lot is not set to expire until 30sep2020, and the lot number is 9255587.While our phlebotomist was attempting to draw blood, she would pierce the top of the vacutainers and no vacuum would be generated, causing her to have to use multiple tubes for one 3.5ml blood draw.This created a discomfort for our subjects, who already may have had anxiety about the blood draw, and made our phlebotomist look inexperienced, leading to her feeling discouraged.We like to use bd vacutainers for these collections, but this set of vacutainers has been completely unreliable.
Additional Manufacturer Narrative
Investigation summary: bd received 14 samples from the customer for investigation.All samples were evaluated by draw testing and the indicated failure mode for underfill with the incident lot was not observed as all product specifications were met.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 non-conformances during manufacturing of the product.
Event or Problem Description
It was reported that under filling is occurring during use with a bd vacutainer® sst¿ blood collection tubes.The following information was provided by the initial reporter: i work for a medical device company, and while collecting venipuncture blood for a research study, we have had multiple problems with one lot of bd sst-vacutainers.The lot is not set to expire until 30sep2020, and the lot number is 9255587.While our phlebotomist was attempting to draw blood, she would pierce the top of the vacutainers and no vacuum would be generated, causing her to have to use multiple tubes for one 3.5ml blood draw.This created a discomfort for our subjects, who already may have had anxiety about the blood draw, and made our phlebotomist look inexperienced, leading to her feeling discouraged.We like to use bd vacutainers for these collections, but this set of vacutainers has been completely unreliable.

• 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: 10139042
• Report Number: 1024879-2020-00386
• Device Sequence Number: 16724158
• Product Code: JKA
• UDI-Device Identifier: 50382903679817
• UDI-Public: 50382903679817
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 367981
• Device Catalogue Number: 367981
• Device Lot Number: 9255587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 06/30/2020
• 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