MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

Catalog Number 383083

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

Patient Problems Erythema (1840); Reaction (2414)

Event Date 12/05/2019

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 was reported that the bd intima-ii¿ closed iv catheter system caused an allergic reaction and required medical intervention.The following information was provided by the initial reporter, translated from (b)(6).Verbatim: ¿the patient was admitted due to fever, and was given q12h intravenous infusion of antibiotics after admission.In order to reduce the frequency and pain of puncture, intravenous indwelling needle was given.The puncture site of the intravenous indwelling needle in the patient was red with secretion and no pain.The indwelling needle was removed to protect the patient with hydrocolloid dressing.

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 8079073.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.Bd will continue to monitor this issue.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system caused an allergic reaction and required medical intervention.The following information was provided by the initial reporter, translated from chinese.Verbatim: ¿the patient was admitted due to fever, and was given q12h intravenous infusion of antibiotics after admission.In order to reduce the frequency and pain of puncture, intravenous indwelling needle was given.The puncture site of the intravenous indwelling needle in the patient was red with secretion and no pain.The indwelling needle was removed to protect the patient with hydrocolloid dressing.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9682743
• MDR Text Key: 182221035
• Report Number: 3006948883-2020-00053
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2021
• Device Catalogue Number: 383083
• Device Lot Number: 8079073
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other