MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS YEL 24GA X 0.75IN QSYTE-CAP Y; INTRAVASCULAR CATHETER

Catalog Number 383714

Device Problem Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 04/02/2022

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd pegasus yel 24ga x 0.75in qsyte-cap y blood leaked after withdrawal and spattered over the patient, and the nurse's arm and eyes.The following information was provided by the initial reporter: blood leakage from the septum was found on withdrawal of the needle core and blood spatter was found on the patient's arm and the nurse's arm and eyes.

Manufacturer Narrative

H6: investigation summary: a device history review was conducted for lot number 1354575.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported while using bd pegasus yel 24ga x 0.75in qsyte-cap y blood leaked after withdrawal and spattered over the patient, and the nurse's arm and eyes.The following information was provided by the initial reporter: blood leakage from the septum was found on withdrawal of the needle core and blood spatter was found on the patient's arm and the nurse's arm and eyes.

• Brand Name: BD PEGASUS YEL 24GA X 0.75IN QSYTE-CAP Y
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14197576
• MDR Text Key: 290056896
• Report Number: 8041187-2022-00216
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383714
• Device Lot Number: 1354575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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