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

Catalog Number 383712

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

Patient Problems Bacterial Infection (1735); Fever (1858); Urticaria (2278)

Event Date 03/14/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a (b)(6) female patient was hospitalized due to appendicitis.Surgery was performed and a bd pegasus safety closed iv catheter system was placed in the patient.The day after the surgery, the patient developed a fever and urticaria.Blood cultures were collected from the patient, tested positive, and the patient was treated with dexamethasone and antibiotics.Of note, it was also reported that the hospital where the incident occurred conducted an investigation and confirmed that the iv catheter reported was not the cause of the reported fever.

Manufacturer Narrative

One unused and sealed sample was returned for evaluation.A visual/microscopic inspection revealed no irregularities and an endotoxin inspection met requirements (20 eu/device).A review of the device history record, incoming/outgoing inspection, packaging, and sterility record revealed no irregularities during the manufacture and sterilization of the reported lot # 5169315.An absolute root cause for this incident cannot be determined.Additionally, our quality engineer notes that the incident is not related to the manufacturing process of the device.The device evaluation summary is detailed.

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5536674
• MDR Text Key: 41522283
• Report Number: 3006948883-2016-00011
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 383712
• Device Lot Number: 5169315
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2015
• 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
• Patient Age: 6 YR