MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN/EC SLM; INTERVASCULAR CATHETER

Catalog Number 383012

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Reaction, Injection Site (2442); Skin Inflammation (2443)

Event Date 06/14/2019

Event Type  Injury  

Manufacturer Narrative

Investigation summary: phlebitis: in response to the event reported by your facility a device history review was conducted for lot number 7356351.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.Investigation conclusion: a sample could not be obtained for evaluation and testing root cause description: without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that a allergic reaction occurred with a intima-ii y 20gax1.16in prn/ec slm.The following information was provided by the initial reporter, "the patient was hospitalized for edema when (b)(6) 2019, after using the catheter for 10 hours (normal medication used, details unavailable), the patient's injection site was red and swollen, and the face was painful.Then doctor examined the patient and found no rash, nausea or other symptoms.Thus, only removed the catheter from patient.4 hours after removing the catheter, symptoms gradually improved.".

• Brand Name: INTIMA-II Y 20GAX1.16IN PRN/EC SLM
• Type of Device: INTERVASCULAR 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 ; 8015652341
• MDR Report Key: 8799258
• MDR Text Key: 151334782
• Report Number: 3006948883-2019-00562
• 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,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Catalogue Number: 383012
• Device Lot Number: 7356351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• 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