MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 368774

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: bd did not receive photos or samples and the lot number is unknown.Therefore, the investigation is limited.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.A complaint history review and device history record review could not be conducted since the lot number was not provided.Per the instructions for use for this product: "if tubes are not mixed 5 to 6 times immediately after collection, incomplete separation of serum may occur.This may also result in delayed clotting and fibrin formation." "separation of serum from cells by centrifugation should take place within 2 hours of collection to prevent erroneous test results"."overfilling or underfilling of tubes will result in an incorrect blood-to-additive ratio and may lead to incorrect analytic results or poor product performance".Complaints received for this 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.Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that bd vacutainer¿ rapid serum tube (rst) blood collection tubes thrombin had poor separator movement.The following information was provided by the initial reporter: "after refrigeration the tube is centrifuged and the gel is still at the bottom of the tube.Have requested more details on centrifugation, sample processing, temperature, sample collection end to end protocol to centrifugation.".

• Brand Name: BD VACUTAINER RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11127259
• MDR Text Key: 226318019
• Report Number: 2243072-2020-02298
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903687744
• UDI-Public: 50382903687744
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 368774
• Device Catalogue Number: 368774
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1