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

Catalog Number 383069

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

Patient Problems Local Reaction (2035); Skin Inflammation (2443)

Event Date 09/08/2019

Event Type  Injury  

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 adverse effects without apparent device misuse or problem during use.The following has been provided by the initial reporter: on (b)(6) 2019, the patient came to our hospital for viral influenza.It needed to be infused for three days.The doctor used a closed intravenous indwelling needle for infusion.The next day, there was redness at the puncture site.The doctor replaced the closed intravenous indwelling needle and with anti-inflammatory treatment.Better after 1 day.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8358924.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.Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It has been reported that one bd intima-ii¿ closed iv catheter system has been found experiencing adverse effects without apparent device misuse or problem during use.The following has been provided by the initial reporter: on (b)(6) 2019, the patient came to our hospital for viral influenza.It needed to be infused for three days.The doctor used a closed intravenous indwelling needle for infusion.The next day, there was redness at the puncture site.The doctor replaced the closed intravenous indwelling needle and with anti-inflammatory treatment.Better after 1 day.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9189359
• MDR Text Key: 164022309
• Report Number: 3006948883-2019-00864
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2022
• Device Catalogue Number: 383069
• Device Lot Number: 8358924
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention