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

Catalog Number 383078

Device Problem Leak/Splash (1354)

Patient Problems Bronchitis (1752); Hemorrhage/Bleeding (1888); Reaction (2414)

Event Date 07/01/2019

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 blood leakage at prn during the process of penetration.The patient was coughing and coughing for more than 2 years, and he was admitted to hospital in january.He was diagnosed with acute exacerbation of chronic bronchitis.After admission, he was given an intravenous infusion of cough and phlegm and anti-inflammatory drugs.At (b)(6) 2019 10:02, hemorrhage occurred in the closed vein of the hemorrhagic cap healin cap during the puncture.There was a risk of infusion reaction and occupational exposure.Replace the indwelling needle heparin and explain the work to 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 blood leakage at prn during the process of penetration.The patient was coughing and coughing for more than 2 years, and he was admitted to hospital in (b)(6).He was diagnosed with acute exacerbation of chronic bronchitis.After admission, he was given an intravenous infusion of cough and phlegm and anti-inflammatory drugs.At (b)(6) 2019 10:02, hemorrhage occurred in the closed vein of the hemorrhagic cap healin cap during the puncture.There was a risk of infusion reaction and occupational exposure.Replace the indwelling needle heparin and explain the work to the patient.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 9023805.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.H3 other text : see h.10.

• 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: 8916301
• MDR Text Key: 155528932
• Report Number: 3006948883-2019-00682
• 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: 02/11/2022
• Device Catalogue Number: 383078
• Device Lot Number: 9023805
• 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