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

Catalog Number 383712

Device Problem Leak/Splash (1354)

Patient Problems Extravasation (1842); Weakness (2145); Numbness (2415)

Event Date 08/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use of the bd pegasus¿ safety closed iv catheter system there was leakage at the joint.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: the patient was admitted to the hospital because of "left limb weakness and numbness for 2 days".After 5 minutes of infusion, the indwelling needle was found to be infiltrated.It was found that the heparin cap joint leaked.Check that the joint has been tightened and replace the indwelling needle to re-infuse.

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 9081793.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.A sample could not be obtained for evaluation and testing.Retained samples were leak tested with no leakage observed.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 during use of the bd pegasus¿ safety closed iv catheter system there was leakage at the joint.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to the hospital because of "left limb weakness and numbness for 2 days".After 5 minutes of infusion, the indwelling needle was found to be infiltrated.It was found that the heparin cap joint leaked.Check that the joint has been tightened and replace the indwelling needle to re-infuse.

• 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
• MDR Report Key: 9145662
• MDR Text Key: 167364476
• Report Number: 8041187-2019-00780
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: PENDING
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 383712
• Device Lot Number: 9081793
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other