MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problem Fluid Discharge (2686)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed.And the (b)(4) fda registration number has been used for the manufacture report number.Investigation summary: bd had not received samples or photos from your facility for evaluation.Additionally, we were unable to determine the specific lot number associated with this complaint.Therefore, a review of the manufacturing records could not be conducted.Bd is continually monitoring complaints received for this device and reported condition in order to identify emerging trends.

Event Description

It was reported when using the unspecified bd vacutainer blood collection tubes , the device experienced stopper pops out of the tube.The following information was provided by the initial reporter.The customer stated: it is reported customer experienced 2 occurrences of stoppers popping off.During one occurrence an employee was exposed to blood.Verbiage received: "alerting you to a potential issue with the bd vacutainer blood collection tubes with green tops.A user reported pressure built up during mixing and the cap failed spraying the user in the face.This occurred on two separate occasions, (b)(6) and (b)(6) at the kaiser permanente capitol hill/seattle hospital.Product name: bd vacutainer blood collection tube (green).Lot number: b210136d, ref# 4540089.Any harm? yes, blood splash to the eyes.What is the issue you experienced? an urgent care nurse reported lightly vibrating the tube after blood draw to mix blood product.Once shaking stopped and finger removed from top, the cap burst off and blood erupted spraying the user, wall, and ceiling.The nurse is experienced with blood draws and has not previously encountered issues.No issues with same lot from lab users.Sample available? yes, i believe there were some clean tubes from the same lot preserved in the urgent care and lab departments." 07-july-2021 @ 3:45pm cst: i spoke with customer whom confirmed employee did receive post-exposure testing with no issues with any results.Date of event for exposure was (b)(6) 2021.This was the only date exposure occurred.No other information available.Employees were inverting these vacutainers by hand when stopper popped off.

• Brand Name: UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12204371
• MDR Text Key: 262712325
• Report Number: 2243072-2021-01939
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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