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

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/02/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: material #: unknown.Lot/batch #: unknown.Bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the unspecified bd vacutainer experienced glass breakage during use.The product defect led to a drop in the patient's blood pressure that required iv fluid administration.The following information was provided by the initial reporter: it was reported that the vacutamer at end of 20ga iv line to obtain blood.Vacutamer broke off at iv connector site.Unable to remove vacutainer from the line.Line had to be removed.This resulted in a delay in care for a patient to receive emergent iv fluids with a blood pressure of 78/41.

• Brand Name: UNSPECIFIED BD VACUTAINER
• 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: 12866306
• MDR Text Key: 286050295
• Report Number: 2243072-2021-02810
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/23/2021
• 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): Required Intervention