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

Catalog Number 383912

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

Patient Problems Abscess (1690); Erythema (1840); Phlebitis (2004)

Event Date 05/14/2022

Event Type  Injury  

Event Description

It was reported that the bd bd pegasus¿ safety closed iv catheter system cause large abscess, which was treated with suppuration and bloodletting followed by medication.The following information was provided by the initial reporter, translated from (b)(6) to english: the head nurse of the thoracic surgery department found that the puncture site of the patient was red and swollen from one to two days after the puncture, and the doctor confirmed the occurrence of severe phlebitis.One of the severe cases had a large abscess, which was treated by the nurse with suppuration and bloodletting, followed by medication.

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 bd bd pegasus¿ safety closed iv catheter system cause large abscess, which was treated with suppuration and bloodletting followed by medication.The following information was provided by the initial reporter, translated from chinese to english: the head nurse of the thoracic surgery department found that the puncture site of the patient was red and swollen from one to two days after the puncture, and the doctor confirmed the occurrence of severe phlebitis.One of the severe cases had a large abscess, which was treated by the nurse with suppuration and bloodletting, followed by medication.

Manufacturer Narrative

H.6 investigation summary: one photo was received by our quality team for evaluation.The photo shows the patient¿s hand has returned to normal and the swelling at the puncture site has been reduced.The back of the hand is red and swollen, and the entire back of the hand is dirty, and it can be seen that it has not been cleaned enough.In response to the event reported by the facility a device history review was conducted for lot number 2018793.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: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14657230
• MDR Text Key: 294851971
• Report Number: 3014704491-2022-00214
• 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,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 383912
• Device Lot Number: 2018793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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
• Patient Outcome(s): Required Intervention