MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

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

Patient Problems Erythema (1840); Pain (1994); Phlebitis (2004); Swelling (2091); Reaction, Injection Site (2442)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Initial reporter phone #: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during use phlebitis occurred with an unspecified bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: on (b)(6) 2019, at 12:00, the nurse follow the doctor's advice to give the patient 0.9%ns250ml+ 10mg sodium aescinate intravenous infusion, and hermetic venous indwelling needle puncturing, at 12:05, while touring the inpatient ward, the patient complained pain at puncture, it found that the patient was redness and swelling at puncture, immediately stopped infusion for the patient and inform the doctor to take anti allergic medication, by 17:20, the pain and redness of the patient gradually subsided and no other adverse effects were found.

Event Description

It was reported that during use phlebitis occurred with an unspecified bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2019, at 12:00, the nurse follow the doctor's advice to give the patient 0.9%ns250ml+ 10mg sodium aescinate intravenous infusion, and hermetic venous indwelling needle puncturing, at 12:05, while touring the inpatient ward, the patient complained pain at puncture, it found that the patient was redness and swelling at puncture, immediately stopped infusion for the patient and inform the doctor to take anti allergic medication, by 17:20, the pain and redness of the patient gradually subsided and no other adverse effects were found.

Manufacturer Narrative

H.6.Investigation summary since a lot number could not be connected to the device identified in the complaint, bd investigators could not conduct a device history review for this event.Additionally, a sample has not yet been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in the description of the event.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.

• Brand Name: UNSPECIFIED BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9534207
• MDR Text Key: 174310922
• Report Number: 2243072-2019-02920
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other