MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD¿ TUBE K2EDTA PLH 13X75 3.0 PLBL LAV BR; CONTAINMENT TUBE

Catalog Number 360056

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

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

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the bd¿ tube k2edta plh 13x75 3.0 plbl lav br has been found experiencing low draw during use.The following has been provided by the initial reporter: lower than expected vacuum pickup.The customer has informed that they were using tubes close to the expiration date and is stated that those tubes have the volume aspirated very below from the reference mark and also the aspiration speed is very slow.The customer is using another lot with longer expiration date and relates that the volume aspirated is closer to the reference mark and faster.Also, it was determined that the tubes is having acceptable aspirated volume with only 0,1 ml below the reference mark (the acceptable variation is +- 10%).This volume was verified with syringes.

Manufacturer Narrative

H.6.Investigation summary bd received samples and photos from the customer facility for investigation.The photos were evaluated and the indicated failure mode for underfill with the incident lot was observed.Draw testing was performed on the returned samples and on bd retention samples (selected from bd inventory) and upon completion, no underfill was observed.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.H3 other text : see section h.10.

Event Description

It has been reported that the bd¿ tube k2edta plh 13x75 3.0 plbl lav br has been found experiencing low draw during use.The following has been provided by the initial reporter: lower than expected vacuum pickup.The customer has informed that they were using tubes close to the expiration date and is stated that those tubes have the volume aspirated very below from the reference mark and also the aspiration speed is very slow.The customer is using another lot with longer expiration date and relates that the volume aspirated is closer to the reference mark and faster.Also, it was determined that the tubes is having acceptable aspirated volume with only 0,1 ml below the reference mark (the acceptable variation is +- 10%).This volume was verified with syringes.

• Brand Name: BD¿ TUBE K2EDTA PLH 13X75 3.0 PLBL LAV BR
• Type of Device: CONTAINMENT TUBE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 9536397
• MDR Text Key: 203533233
• Report Number: 3003916417-2019-00650
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 360056
• Device Lot Number: 9151726
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other