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

Catalog Number 383711

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Inflammation (1932)

Event Date 09/16/2018

Event Type  Injury  

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 there was difficulty removing the bd pegasus¿ safety closed iv catheter system from the patient, and the puncture site was "red and showed potential phlebitis".After removal of the catheter, the puncture site was treated with "iodine fu disinfection".Medication of "the drug cephalosporin sodium, 5% glucose, (b)(6), electrolyte, vitamin b6, vitamin c" was administered, though it is unknown if these medications were being received before or after the possible ¿phlebitis¿.The phlebitis was reported to have ¿eased¿ the following day after catheter removal.

Event Description

It was reported that there was difficulty removing the bd pegasus¿ safety closed iv catheter system from the patient, and the puncture site was "red and showed potential phlebitis".After removal of the catheter, the puncture site was treated with "iodine fu disinfection".Medication of "the drug cephalosporin sodium, 5% glucose, yan hu ning, electrolyte, vitamin b6, vitamin c" was administered, though it is unknown if these medications were being received before or after the possible ¿phlebitis¿.The phlebitis was reported to have ¿eased¿ the following day after catheter removal.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8044406.Records show it was assembled from 1/24/2018-1/29/2018, and determined that this is the only instance of difficult removal of a catheter occurring in this batch of product.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 of packaged goods.The sample submitted by the facility was evaluated by our team of qualified quality investigators.No abnormalities were able to be identified in the tubing that could have resulted in the reported event.Unfortunately, the root cause for this complaint could not be determined at the conclusion of our review; bd will continue to track and trend for this issue.

• 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: 7957021
• MDR Text Key: 123433009
• Report Number: 8041187-2018-00363
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

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: 02/28/2021
• Device Catalogue Number: 383711
• Device Lot Number: 8044406
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 MO