MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

Catalog Number 383912

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling (2091)

Event Date 04/17/2020

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.(b)(4).

Event Description

It was reported that bd pegasus safety closed iv catheter system was used and the nurse found that the patient puncture site was red and swollen.This was discovered during use.The following information was provided by the initial reporter: at 09:00 on (b)(6) 2020, the patient's venipuncture was kept in strict accordance with aseptic operation.The puncture was successful and blood return could be seen and properly fixed.The patient complained of local pain at 11:00.The nurse found that the puncture site was redness and swellness, there was about 1 x 1cm of indentation and the blood return unblocked, immediately removed the indwelling needle, applied a wet compress of 50% magnesium sulfate solution, irradiate with infrared light, and applied mupirocin ointment and comforted the patient's mood.

Event Description

It was reported that bd pegasus¿ safety closed iv catheter system was used and the nurse found that the patient puncture site was red and swollen.This was discovered during use.The following information was provided by the initial reporter: at 09:00 on (b)(6) 2020, the patient's venipuncture was kept in strict accordance with aseptic operation.The puncture was successful and blood return could be seen and properly fixed.The patient complained of local pain at 11:00.The nurse found that the puncture site was redness and swellness, there was about 1 x 1cm of indentation and the blood return unblocked, immediately removed the indwelling needle, applied a wet compress of 50% magnesium sulfate solution, irradiate with infrared light, and applied mupirocin ointment and comforted the patient's mood.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 9316868.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 sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 10131292
• MDR Text Key: 194508555
• Report Number: 3006948883-2020-00223
• Device Sequence Number: 1
• Product Code: FPA
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/22/2022
• Device Catalogue Number: 383912
• Device Lot Number: 9316868
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention