MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 15.8 MG; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 362799

Device Problems Incorrect Measurement (1383); No Device Output (1435); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 70 bd vacutainer® ppt¿ plasma preparation tubes k2e 15.8 mg experienced oil gel globules and clogged/blocked probes.Product defect was noted during use.The following information was provided by the initial reporter: the blood station has purchased bd nucleic acid tubes, and the quality is stable during the period.Until august 2020, the batch number is 0072401, and there are 3000 8.5ml nucleic acid tubes with the material number 362799.Currently, about 1,500 are in use.The instrument has not been updated recently, and it has been standardized operation.However, the inspection department said that the needle was blocked and the instrument was malfunctioning.From the inspection department director, he said that there were only one or two occasions before, but now it is 8 since the beginning of the month, it was discovered that about 70 tubes (1500 tubes used) were found to have a layer of milky white substance in the blood plasma of the nucleic acid tube, which caused the blocking of the needle during the test.Therefore, it is suspected that the cause is the quality of the blood collection tube.

Event Description

It was reported that 70 bd vacutainer® ppt¿ plasma preparation tubes k2e 15.8 mg experienced oil gel globules and clogged/blocked probes.Product defect was noted during use.The following information was provided by the initial reporter: the blood station has purchased bd nucleic acid tubes, and the quality is stable during the period.Until (b)(6)2020 , the batch number is 0072401, and there are 3000 8.5ml nucleic acid tubes with the material number 362799.Currently, about(b)(4) are in use.The instrument has not been updated recently, and it has been standardized operation.However, the inspection department said that the needle was blocked and the instrument was malfunctioning.From the inspection department director, he said that there were only one or two occasions before, but now it is 8 since the beginning of the month, it was discovered that about (b)(4) tubes ((b)(4) tubes used) were found to have a layer of milky white substance in the blood plasma of the nucleic acid tube, which caused the blocking of the needle during the test.Therefore, it is suspected that the cause is the quality of the blood collection tube.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-10-29.H6: investigation summary bd received (b)(4) samples and (b)(4) photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for oil gel globules with the incident lot was observed.Additionally, the customer samples were evaluated visually and the indicated failure mode for oil gel globules with the incident lot was not observed in the sample returns.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.A complaint history was completed, and this complaint is the 1st complaint received for this defect on this lot number.Based on the investigation to date, no further testing is needed at this time.Proper collection techniques for collection of ppt¿ tubes should be followed, including: immediate and gentle inversions of (b)(4) to (b)(4) times, proper storage and centrifugation ((b)(4) rcf for (b)(4) minutes) or customer validated alternative to processing/storage protocols that differ from bd ifu, separation of plasma from cells by centrifugation should take place within (b)(4) hours of collection.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.H3 other text : see h.10.

• Brand Name: BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 15.8 MG
• 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: 10703635
• MDR Text Key: 214162221
• Report Number: 1917413-2020-00961
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903627993
• UDI-Public: 50382903627993
• Combination Product (y/n): N
• PMA/PMN Number: K972075
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Model Number: 362799
• Device Catalogue Number: 362799
• Device Lot Number: 0072401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1