MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA TUBE K2EDTA PLH 13X75 2.0 PLBL LAV BR; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 360055

Device Problems Coagulation in Device or Device Ingredient (1096); Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

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 when using the tube k2edta plh 13x75 2.0 plbl lav br there was insufficient additive quantity.This event occurred 10 times.The following information was provided by the initial reporter: translated to english.The customer stated: customer reports cell ring formation in the wall of the tube.Add info received: was there any patient impact due to issue? r: unknown; how many tubes have been affected? r: it was observed the meniscus and walls of the tube with cells adhered in more than 30 samples on (b)(6) 2021, being samples from different departments; how were the tubes mixed after the collection? r: 8 to 10 times of inversion; at what conditions of temperature and humidity were the tubes stored prior to use? r: temperatures under 25°c; were the samples exposed to high temperatures during processing? r: were not; could you please confirm the draw volume of each tube? 0151862, 2 ml and 0344051, 4 ml; there were variation of those volumes in the observed samples.But even the samples with the correct volume were presenting the meniscus; have the tubes been transported in vertical or in non-vertical position? r: the tubes are transported lying down; however, some tubes haven't been transported because the collections were made at the same site of the processing; are tubes stored upright or on its side, after collection? r: upright; are there tubes (samples) of the same batch, but not used, available for evaluation? r: yes, there is 1 tube of each batch.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-04-30.H6: investigation summary: bd received 1 samples and 4 photos for investigation.The photos were reviewed and the indicated failure mode for red cell ring and microclots was observed.Erroneous results cannot be confirmed from the photos.Additionally, the customer sample was evaluated visually for edta content.And no visual defects were found.The spray distribution is according to the product specifications.195 retention samples of the incident lot selected from bd inventory and were visually evaluated and no visual defects were observed.Retention samples were further tested and no issues relating to red cell ring, microclot, or erroneous results were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate the customer¿s indicated failure (erroneous results, red cell ring, microclots) because the defect was not evident in the testing of the complaint lot (retention) samples.Replicates of both complaint and control samples tested were acceptable in terms of both precision and accuracy (validations attached).Laboratory visual evaluations of retain samples indicated that the edta tubes performed as expected.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.This complaint has been confirmed for red cell ring and microclots based on the photos provided.A root cause could not be determined h3 other text : see h10.

Event Description

It was reported when using the tube k2edta plh 13x75 2.0 plbl lav br there was insufficient additive quantity.This event occurred 10 times.The following information was provided by the initial reporter: translated to english.The customer stated: customer reports cell ring formation in the wall of the tube.Add info received: - was there any patient impact due to issue? r: unknown; - how many tubes have been affected? r: it was observed the meniscus and walls of the tube with cells adhered in more than 30 samples on 3/01/2021, being samples from different departments; - how were the tubes mixed after the collection? r: 8 to 10 times of inversion; - at what conditions of temperature and humidity were the tubes stored prior to use? r: temperatures under 25°c; - were the samples exposed to high temperatures during processing? r: were not; - could you please confirm the draw volume of each tube? 0151862, 2 ml and 0344051, 4 ml; there were variation of those volumes in the observed samples.But even the samples with the correct volume were presenting the meniscus; - have the tubes been transported in vertical or in non-vertical position? r: the tubes are transported lying down; however, some tubes haven't been transported because the collections were made at the same site of the processing; - are tubes stored upright or on its side, after collection? r: upright; - are there tubes (samples) of the same batch, but not used, available for evaluation? r: yes, there is 1 tube of each batch.2 additional failure modes added to the complaint.Microclots and erroneous results.They have been questioning of discrepancy on the result of a hemoglobin of 17.5 g / dl, female patient with a history of normal hemoglobin result (12.5 g / dl).

Event Description

It was reported when using the tube k2edta plh 13x75 2.0 plbl lav br there was insufficient additive quantity.This event occurred 10 times.The following information was provided by the initial reporter: translated to english.The customer stated: customer reports cell ring formation in the wall of the tube.Add info received: - was there any patient impact due to issue? r: unknown; - how many tubes have been affected? r: it was observed the meniscus and walls of the tube with cells adhered in more than 30 samples on 3/01/2021, being samples from different departments; - how were the tubes mixed after the collection? r: 8 to 10 times of inversion; - at what conditions of temperature and humidity were the tubes stored prior to use? r: temperatures under 25°c; - were the samples exposed to high temperatures during processing? r: were not; - could you please confirm the draw volume of each tube? 0151862, 2 ml and 0344051, 4 ml; there were variation of those volumes in the observed samples.But even the samples with the correct volume were presenting the meniscus; - have the tubes been transported in vertical or in non-vertical position? r: the tubes are transported lying down; however, some tubes haven't been transported because the collections were made at the same site of the processing; - are tubes stored upright or on its side, after collection? r: upright; - are there tubes (samples) of the same batch, but not used, available for evaluation? r: yes, there is 1 tube of each batch.2 additional failure modes added to the complaint.Microclots and erroneous results.They have been questioning of discrepancy on the result of a hemoglobin of 17.5 g / dl, female patient with a history of normal hemoglobin result (12.5 g / dl).

Manufacturer Narrative

The following fields were updated due to additional information: patient information (sex): female.The following fields were updated due to corrections.B.1.Adverse event and / or product problem: reported issue is both an adverse event and product problem.B.2.Outcomes attributed to adverse event: other.B.5.Describe event description : r: they have been questioning of discrepancy on the result of a hemoglobin of 17.5 g / dl, female patient with a history of normal hemoglobin result (12.5 g / dl)." f.3.Imdrf annex a grid: fda device code: a0908, a030202.H.1.Type of reportable event: serious injury.

• Brand Name: TUBE K2EDTA PLH 13X75 2.0 PLBL LAV BR
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 11543753
• MDR Text Key: 273876659
• Report Number: 3003916417-2021-00060
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 360055
• Device Lot Number: 0151862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Date Manufacturer Received: 05/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other