MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER

Catalog Number 383019

Device Problem Complete Blockage (1094)

Patient Problems Pain (1994); Skin Irritation (2076); Swelling (2091)

Event Date 12/17/2019

Event Type  malfunction  

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 a catheter kink occurred during use with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, "on (b)(6) 2019, due to weakness of uterine contractions, the patient received intravenous infusion of oxytocin as instructed by the doctor.During the process of puncture with closed intravenous indwelling needle, the hose appeared to bend and break after the needle was pulled out, resulting in pain, redness and swelling at the site of intravenous infusion.Removed indwelling needle immediately and gave replacement.".

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• 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: 9599148
• MDR Text Key: 180720375
• Report Number: 3006948883-2020-00019
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2020

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: Other
• Device Expiration Date: 09/21/2021
• Device Catalogue Number: 383019
• Device Lot Number: 8233303
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2018
• 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): Other