MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383714

Device Problem Fluid/Blood Leak (1250)

Patient Problems Pain (1994); Anxiety (2328)

Event Date 03/02/2022

Event Type  malfunction  

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system leaked from the indwelling needle tube five minutes after starting the infusion.The following information was provided by the initial reporter, translated from (b)(6): "at 8:39 on (b)(6) 2022, the nurse in ward 3 of the hospital used the closed anti-needle puncture intravenous indwelling needle infusion for a patient with malignant melanoma.The indwelling process was smooth.After 5 minutes of infusion, the fluid slowly leaked from the indwelling needle hose, which was immediately stopped and the indwelling needle was re-punctuated.In subsequent operations, no similar problems were found in the same batch of products.The occurrence of this adverse event not only increases the patient's pain and anxiety (the patient is suffering from malignant disease and feels that the waste of liquid medicine affects the treatment effect) but also increases the cost of the patient.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: a device history review was conducted for lot number 1294439.Our records show that this is the only instance of this issue occurring in this production batch.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.Additionally a video was submitted which displayed a leak originating from the middle of the extension tubing.The issue has been confirmed.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 that the bd pegasus¿ safety closed iv catheter system leaked from the indwelling needle tube five minutes after starting the infusion.The following information was provided by the initial reporter, translated from chinese: "at 8:39 on march 2, 2022, the nurse in ward 3 of the hospital used the closed anti-needle puncture intravenous indwelling needle infusion for a patient with malignant melanoma.The indwelling process was smooth.After 5 minutes of infusion, the fluid slowly leaked from the indwelling needle hose, which was immediately stopped and the indwelling needle was re-punctuated.In subsequent operations, no similar problems were found in the same batch of products.The occurrence of this adverse event not only increases the patient's pain and anxiety (the patient is suffering from malignant disease and feels that the waste of liquid medicine affects the treatment effect) but also increases the cost of the patient.".

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• 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: 14190581
• MDR Text Key: 289994352
• Report Number: 8041187-2022-00214
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383714
• Device Lot Number: 1294439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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