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

Model Number	367981
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9064643.Medical device expiration date: 2020-02-29.Device manufacture date: 2019-03-05.Medical device lot #: 9123804.Medical device expiration date: 2020-04-30.Device manufacture date: 2019-05-03.Medical device lot #: 9123802.Medical device expiration date: 2020-04-30.Device manufacture date: 2019-05-03.
Event or Problem Description
It was reported that an unspecified number of bd vacutainer® sst¿ blood collection tubes experienced erroneous results which were noted during use.The following information was provided by the initial reporter: material no.367981, batch no.9064643, 9123804, 9123802.Complaint 1 of 3.Started seeing increase in august and has been increasing in frequency.No visible hemolysis.Customer is well versed in troubleshooting and has additional data if needed.Problem k+'s are not limited to one site or phlebotomist, nurse.Tubes are draw in various manner-straight, lines etc.They mix 5 times, clot at least 30 minutes, no respinning, spinning according to recommendations, use correct order of draw.Their reference range is 3.6-5.2 and they are running up to 6.4 currently.They run on a beckman dxci 600.They do not draw or run plasma samples.There is no visible hemolysis.They have decanted and sent the serum to labcorp and they get the same results.She had her phlebotomy supervisor draw patients using 4 sst tubes labelled 1,2,3,and 4.The results were as follows for tubes,1,2,3 and 4.5.0, 5.0, 5.5, 5.0 second patient 5.4, 6.1, 5.3, 5.4.She also had a patient that had been running at 4.4 and was drawn in am and was 5.3 and upon redraw at 12:30 was 4.1.Customer didn't have rate of high k+ but report that they are having more high k+ more frequently than last year.
Additional Manufacturer Narrative
H.6.Investigation: bd received samples from the customer facility for investigation.Additionally, retention samples were selected from bd inventory for evaluation.The samples were evaluated and the customer's indicated failure mode for erroneous results with the incident lot was not observed.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.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure (erroneous results) because the defect was not evident in the testing of the retention lot samples.Replicates of both retain and control samples tested were acceptable in terms of both precision and accuracy.
Event or Problem Description
It was reported that an unspecified number of bd vacutainer® sst¿ blood collection tubes experienced erroneous results which were noted during use.The following information was provided by the initial reporter: material no.367981 batch no.9064643, 9123804, 9123802.Complaint 1 of 3.Started seeing increase in august and has been increasing in frequency.No visible hemolysis.Customer is well versed in troubleshooting and has additional data if needed.Problem k+'s are not limited to one site or phlebotomist, nurse.Tubes are draw in various manner-straight, lines etc.They mix 5 times, clot at least 30 minutes, no respinning, spinning according to recommendations, use correct order of draw.Their reference range is 3.6-5.2 and they are running up to 6.4 currently.They run on a beckman dxci 600.They do not draw or run plasma samples.There is no visible hemolysis.They have decanted and sent the serum to (b)(4) and they get the same results.She had her phlebotomy supervisor draw patients using 4 sst tubes labelled 1,2,3,and 4.The results were as follows for tubes,1,2,3 and 4.5.0, 5.0, 5.5, 5.0 second patient 5.4, 6.1, 5.3, 5.4.She also had a patient that had been running at 4.4 and was drawn in am and was 5.3 and upon redraw at 12:30 was 4.1.Customer didn't have rate of high k+ but report that they are having more high k+ more frequently than last year.

• 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: 9355322
• Report Number: 1024879-2019-02004
• Device Sequence Number: 535205
• Product Code: JKA
• UDI-Device Identifier: 50382903679817
• UDI-Public: 50382903679817
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/30/2020

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 Model Number: 367981
• Device Catalogue Number: 367981
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 03/30/2020
• 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