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

Catalog Number 383751

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Swelling (2091)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the safety device on the bd pegasus¿ safety closed iv catheter system was difficult to remove during use, as it was "stuck".Once pulled apart, the patient's hands were left "swollen" and the shield couldn't be detached.The following information was provided by the initial reporter, translated from (b)(6) to english: "during the puncturing, the anti-puncturing device of needle couldn't be removed, and the back-drawing device was stuck.After pulling it apart, the patient's hand was swollen and the protection device couldn't be detached.".

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 9268686.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.Although photos were submitted for evaluation, for this failure mode we are not able to determine the root cause without the ability to evaluate the affected device.

Event Description

It was reported that the safety device on the bd pegasus¿ safety closed iv catheter system was difficult to remove during use, as it was "stuck".Once pulled apart, the patient's hands were left "swollen" and the shield couldn't be detached.The following information was provided by the initial reporter, translated from chinese to english: "during the puncturing, the anti-puncturing device of needle couldn't be removed, and the back-drawing device was stuck.After pulling it apart, the patient's hand was swollen and the protection device couldn't be detached.".

• 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: 10043875
• MDR Text Key: 191312923
• Report Number: 8041187-2020-00249
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 383751
• Device Lot Number: 9268686
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other