MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366667
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® lithium heparin (lh) blood collection tubes.The device experienced erroneous results.This event occurred three times.The following information was provided by the initial reporter.The customer stated: it was reported that tubes are present errors."we are starting to see errors on our machines with specimens drawn in those tubes.Lot# 1350304 exp 04-30-2023 3 separate times 3 separate machines.".
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H6: investigation summary bd had not received samples or photos for investigation.Therefore, retention samples from bd inventory were evaluated.100 retentions were visually inspected with no issues being identified no clinical testing could be performed.The customer has been informed that bd does not have any data for this reported use of this product family.Arterial blood gas analysis on venous blood in this vessel is not consistent with glp(good laboratory practices).In addition, it is a clinically inappropriate sample type for this instrumentation.Arterial blood gas analysis on a vacutainer tube is considered an off label product use.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 unable to be confirmed for instrument issues.This is considered an off-label use of this product.
Event or Problem Description
It was reported when using the bd vacutainer® lithium heparinn (lh) blood collection tubes, the device experienced erroneous results.This event occurred three times.The following information was provided by the initial reporter.The customer stated: it was reported that tubes are present errors."we are starting to see errors on our machines with specimens drawn in those tubes.Lot# 1350304 exp 04-30-2023 3 separate times 3 separate machines.".

• Brand Name: BD VACUTAINER® LITHIUM HEPARINN (LH) 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
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14116319
• Report Number: 1917413-2022-00199
• Device Sequence Number: 19895842
• Product Code: JKA
• UDI-Device Identifier: 00382903666676
• UDI-Public: 00382903666676
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/17/2022

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: 04/30/2023
• Device Catalogue Number: 366667
• Device Lot Number: 1350304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown