MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	369714
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0072572, medical device expiration date:2021-09-30, device manufacture date: 2020-03-12, medical device lot #: 9344028, medical device expiration date: 2021-06-30, device manufacture date: 2019-12-10, medical device lot #: 9315472, medical device expiration date: 2021-05-31, device manufacture date: 2019-11-11.Date of event: unknown.The date received by manufacturer has been used for this field.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 during use the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes experienced erroneous results.This event occurred 3 times.The following information was provided by the initial reporter: the customer stated they experienced erroneous results.The sites are having pt aptt and inr evaluation issues.Additional information: customer states "at present, we have screened 159 subjects into this trial and have never encountered these issues.I can assure you, after confirmation with our lab technicians, there were no outstanding issues of concern with these lab collections and blood flow was normal.Collection and processing of these samples were all completed as required by protocol and lab manual specimen collection guidelines.I can confirm that our staff has remained consistent throughout this trial, as there have been no staff changes.The only issue i can think of that is beyond our control is the transport of samples and ultimately their stability once analyzed.".
Event or Problem Description
It was reported during use the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes experienced erroneous results.This event occurred 3 times.The following information was provided by the initial reporter: the customer stated they experienced erroneous results.The sites are having pt aptt and inr evaluation issues.Additional information: customer states "at present, we have screened 159 subjects into this trial and have never encountered these issues.I can assure you, after confirmation with our lab technicians, there were no outstanding issues of concern with these lab collections and blood flow was normal.Collection and processing of these samples were all completed as required by protocol and lab manual specimen collection guidelines.I can confirm that our staff has remained consistent throughout this trial, as there have been no staff changes.The only issue i can think of that is beyond our control is the transport of samples and ultimately their stability once analyzed.".
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for evaluation.Therefore, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to erroneous results were observed.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 customer lot samples.Replicates of both retain and control samples tested were acceptable in terms of both accuracy and precision.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 not confirmed with regards to erroneous results.Bd was not able to identify a root cause for the indicated failure mode.See h.10.

• Brand Name: BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 10667608
• Report Number: 1917413-2020-00932
• Device Sequence Number: 2898189
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• 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,Followup
• Report Date (Section B): 02/22/2021

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 Model Number: 369714
• Device Catalogue Number: 369714
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 02/21/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 02/22/2021
• 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