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

Catalog Number 367986

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Injury (2348)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

Device expiration date: unknown.(b)(6).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd vacutainer® sst¿ blood collection tubes experienced erroneous results causing a serious injury.The reported information includes: description of the event/incident below: verbatim: material no.367986 batch no.Unknown (provided 8334514, 8166531 and 8248995).It was reported that the patient's were reporting erroneous results.¿it was reported by the customer, that a patient # (b)(6) experienced an erroneous result of high calcium of 10.4 mg/dl during testing.¿ complaint summary detail: this complaint is mdr reportable.Erroneous results due to malfunction or misuse could lead to inappropriate medical treatment and potential serious injury.Patients were redrawn.Event type: erroneous results/ serious injury.

Manufacturer Narrative

Correction: the initial report indicated that the lot number for this incident was unknown.However, three potential lot numbers were provided for this incident.The information for each lot number is as follows: medical device lot #: 8334514.Medical device expiration date: 11/30/2019.Device manufacture date: 11/30/2018.Medical device lot #: 8166531.Medical device expiration date: 6/30/2019.Device manufacture date: 6/15/2018.Medical device lot #: 8248995.Medical device expiration date: 8/31/2019.Device manufacture date: 9/5/2018.Device evaluation: investigation summary: bd had not received samples or photos from the customer facility for investigation; therefore, the investigation was limited.Retention samples were selected from bd inventory for testing.The retain samples had the following analytes performed in triplicate (potassium, calcium, co2) and no issues relating to erroneous results were observed as all results demonstrated satisfactory performance.A review of the device history record was completed for the incident lots 8334514, 8166531 and 8248995 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.Investigation conclusion: based on evaluation of the retain samples, the customer¿s indicated failure mode for erroneous results with the incident lot 8334514, 8166531 and 8248995 was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd vacutainer® sst¿ blood collection tubes experienced erroneous results causing a serious injury.The reported information includes:description of the event/incident below: verbatim: ¿ material no.367986 batch no.Unknown (provided 8334514, 8166531 and 8248995) it was reported that the patient's were reporting erroneous results.¿it was reported by the customer, that a patient #(b)(6) experienced an erroneous result of high calcium of 10.4 mg/dl during testing.¿ "see pr for additional details.Complaint summary detail: this complaint is mdr reportable.Erroneous results due to malfunction or misuse could lead to inappropriate medical treatment and potential serious injury.Patients were redrawn.Event type: erroneous results/ serious injury.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8411809
• MDR Text Key: 138517336
• Report Number: 1024879-2019-00378
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679862
• UDI-Public: 50382903679862
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367986
• Device Lot Number: SEE H.10.
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR