MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® 4NC 0.129M 0.4 ML BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367740

Device Problem Break (1069)

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

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were tested and evaluated and the customer's indicated failure mode for glass breakage with the incident lot was not observed as all product specifications were met.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.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for glass breakage with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.Rationale: 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 use of the bd vacutainer® 4nc 0.129m 0.4 ml blood collection tubes as the tube was being opened to perform the esr test the tube filled with patient blood broke in his hand and cut his finger.Antiretroviral drugs treatment was conducted.This occurred on 2 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: when person opened the tube filled with patient blood, to perform the esr test, the tube broke in his hand and cut his finger.This was the second incident where a tube from the same lot number broke in a person's hand.

• Brand Name: BD VACUTAINER® 4NC 0.129M 0.4 ML BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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 ; 8015652341
• MDR Report Key: 8691968
• MDR Text Key: 147795821
• Report Number: 9617032-2019-00679
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 367740
• Device Lot Number: 8263912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2018
• 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): Required Intervention