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

Catalog Number 367960

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

Patient Problem Injury (2348)

Event Date 05/01/2019

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 an unspecified number of bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tubes experienced erroneous results, causing a serious injury in the form of a patient redraw.The following information was provided by the initial reporter: material no.367960, batch no.9004562.Email received, hello, we have had a few problems with our tubes giving us results that are extremely erroneous.The lot # is 9004562, product #367960.We are getting calcium results that are <0.1 and potassium's of 11.6.

Manufacturer Narrative

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 samples were tested and no issues relating to erroneous results were observed as all results demonstrated satisfactory performance.Retention samples were visually inspected for the presence of additive, all tubes were found to contain spray coating on the inner walls of the tube.Following visual inspection, samples were tested for the quantity of additive that is present in the tube and all samples were within specification requirements.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.To assure high quality specimens, several factors are key.Included, but not limited to this are: proper phlebotomy technique to minimize hemolysis and platelet activation, proper draw order, proper tube fill volume to assure the proper blood-to-additive ratio, gentle and thorough mixing, proper centrifugation conditions-g force and time, and storage conditions.A discard tube must be used when using a winged blood collection set for venipuncture in order to fill the blood collection set tubing¿s ¿dead space¿ with blood.It is not necessary to fill the discard tube completely.This step will ensure maintenance of the proper blood-additive-ratio of the specimen.The discard tube should be a non-additive or coagulation tube.Adherence to proper order of draw for all tubes is essential.Adherence to the recommended specimen handling and processing steps will facilitate acceptable specimen quality and overall performance for reliable analytical outcomes.

Event Description

It was reported that an unspecified number of bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes experienced erroneous results, causing a serious injury in the form of a patient redraw.The following information was provided by the initial reporter: material no.367960, batch no.9004562.Email received, - hello, we have had a few problems with our tubes giving us results that are extremely erroneous.The lot # is 9004562 product #367960.We are getting calcium results that are <0.1 and potassium's of 11.6.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 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: 8619757
• MDR Text Key: 145401281
• Report Number: 1917413-2019-01486
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679602
• UDI-Public: 50382903679602
• Combination Product (y/n): N
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 367960
• Device Lot Number: 9004562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other