MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® LITHIUM HEPARINN 75 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367884

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

Patient Problem No Code Available (3191)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that erroneous results were found after use with a bd vacutainer® lithium heparin 75 usp units blood collection tubes.The following information was provided by the initial reporter, "they are using this batch no : 9158917 from last october ,till date they have already used almost 20000 tubes of same batch ,now suddenly last week they found in 4 to 6 patients in which results of k and cal were enormous." 7000 occurrences were reported.

Event Description

It was reported that erroneous results were found after use with a bd vacutainer® lithium heparinn (b)(4) usp units blood collection tubes.The following information was provided by the initial reporter, "they are using this batch no : 9158917 from last october, till date they have all ready used all most 20000 tubes of same batch ,now suddenly last week they found in 4 to 6 patients in which results of k and cal were enormous." 7000 occurrences were reported.

Manufacturer Narrative

H.6.Investigation summary bd received samples from the customer facility for investigation.The customer samples were evaluated along with retention samples of the incident lot selected from bd inventory.The customer and retention samples were tested 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 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.

• Brand Name: BD VACUTAINER® LITHIUM HEPARINN 75 USP UNITS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 9765168
• MDR Text Key: 186293633
• Report Number: 1917413-2020-00207
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678841
• UDI-Public: 50382903678841
• Combination Product (y/n): N
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2020
• Device Model Number: 367884
• Device Catalogue Number: 367884
• Device Lot Number: 9158917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention