MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER PLASTIC THROMBIN TUBE WITH ORANGE HEMOGARD CLOSURE

Catalog Number 367811

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

Patient Problems Exposure to Body Fluids (1745); Injury (2348)

Event Date 05/24/2018

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 that during us a bd vacutainer plastic thrombin tube with orange hemogard closure malfunctioned as "the nurse assembled the wingset with the luer and the holder, then did the venipuncture.She inserted the tube in the holder and after a while she noticed that the blood was getting out.Then she observed the tube and the bottom was missing.Due to the force applied on the missing bottom, the irregular margins of the tube broke the glove and injured a little her skin, that was therefore in contact with the patient¿s blood." upon further investigation it was found "the nurse told me that the blood was not infected." there was no report of medical intervention needed.

Manufacturer Narrative

Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for evaluation and upon completion, no issues were observed relating to molding defect as all samples met specifications.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.Based on evaluation of the retain samples, the customer¿s indicated failure mode for molding defect with the incident lot was not observed as all samples met the required specifications.Based on the investigation, a root cause could not be determined.The retained product was found to be in conformance and meet release specifications.Complaints received for this device and 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.

Event Description

It was reported that during us a bd vacutainer plastic thrombin tube with orange hemogard closure malfunctioned as "the nurse assembled the wingset with the luer and the holder, then did the venipuncture.She inserted the tube in the holder and after a while she noticed that the blood was getting out.Then she observed the tube and the bottom was missing.Due to the force applied on the missing bottom, the irregular margins of the tube broke the glove and injured a little her skin, that was therefore in contact with the patient¿s blood." upon further investigation it was found "the nurse told me that the blood was not infected." there was no report of medical intervention needed.

• Brand Name: BD VACUTAINER PLASTIC THROMBIN TUBE WITH ORANGE HEMOGARD CLOSURE
• Type of Device: VACUTAINER
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7636497
• MDR Text Key: 112277252
• Report Number: 9617032-2018-00272
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 367811
• Device Lot Number: 8029810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2018
• 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
• Patient Outcome(s): Other