MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383033

Device Problem Leak/Splash (1354)

Patient Problem Ulcer (2274)

Event Date 07/27/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one bd intima-ii¿ closed iv catheter system has been found experiencing leakage during use.The following has been provided by the initial reporter: it's noticed that leakage was found on connection site (y type) after completed penetration.Leakage is still existing after tightening the cap.On (b)(6) 2019 the patient due to the lower limb varicose vein synostic ulcer needs infusion, in the infusion using closed vein retention needle, after the puncture is found that the retention needle y-type interface leakage is obvious, the nurse tightened still leak, immediately replace the retention needle, did not affect the patient.

Event Description

It has been reported that one bd intima-ii¿ closed iv catheter system has been found experiencing leakage during use.The following has been provided by the initial reporter: it's noticed that leakage was found on connection site (y type) after completed penetration.Leakage is still existing after tightening the cap.(b)(6) 2019 the patient due to the lower limb varicose vein synostic ulcer needs infusion, in the infusion using closed vein retention needle, after the puncture is found that the retention needle y-type interface leakage is obvious, the nurse tightened still leak, immediately replace the retention needle, did not affect the patient.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8358943.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.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 8915851
• MDR Text Key: 155529577
• Report Number: 3006948883-2019-00680
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/29/2022
• Device Catalogue Number: 383033
• Device Lot Number: 8358943
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other