MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER LH PST II PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367376

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: bd had not received samples, but 5 photos were provided by the customer for investigation.The photos were reviewed and the indicated failure mode for gel smearing with the incident lot was observed.Additionally, 10 retention samples from bd inventory were evaluated by functional testing.The tubes were drawn with horse blood, mixed, and stood at room temperature for 30 minutes.They were then centrifuged at 3450rpm for 10 minutes using an mse mistral 1000 centrifuge, before being examined under magnification, for any signs of gel smearing.6 of the 10 tubes had slight smears of gel above the barrier on their walls.There are a number of potential root causes to gel on the tube wall post centrifugation, not necessarily device related.Examples such as storage/shipping conditions, and processing factors after the tube has been filled with blood, can contribute to this issue.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 non-conformances during manufacturing of the product.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 100 bd vacutainer® lh pst¿ ii plus blood collection tubes had gel smearing.The following information was provided by the initial reporter: "pst ii tube shows gel smearing.This happens mainly from tubes arriving from out clinic locations.Centrifuge conditions here are: 1800g for 10 minutes, non temperature controlled so around room temperature.It happens in lesser extent also with tubes when phlebotomy has been done on the clinic location itself.Centrifuge conditions here: 1928g for 5 minutes, temperature controlled at 20 degrees celsius.They are seeing gel smearing on and off for some time already but called bd for the first time now to look further into this.Mailed with customer about storage conditions (temp + direct sunligt?) this is still under investigation with the customer but obviously pir has to be submitted asap.".

• Brand Name: BD VACUTAINER LH PST II PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11102046
• MDR Text Key: 228212934
• Report Number: 9617032-2020-01088
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• 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: 12/23/2020

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
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 367376
• Device Lot Number: 0230176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• 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