MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® GLASS PLASMA TUBE WITH LT. BLUE BD HEMOGARD¿; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 369714

Device Problem Break (1069)

Patient Problems Exposure to Body Fluids (1745); Laceration(s) (1946); Injury (2348)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.

Event Description

It was reported that bd vacutainer® glass plasma tubes with lt.Blue bd hemogard¿ broke during centrifuge and resulted in a serious injury.Not knowing a tube was broken, a worker was injured by a splinter of glass as they tried to pull the tube up.The worker was exposed to blood splatter and received medical treatment according to the companies protocol.There have been attempts to contact the customer regarding the injury, but no additional information has been reported by the customer at this time.

• Brand Name: BD VACUTAINER® GLASS PLASMA TUBE WITH LT. BLUE BD HEMOGARD¿
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7970714
• MDR Text Key: 123876455
• Report Number: 1917413-2018-03592
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 369714
• Device Lot Number: 8187771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2018
• 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