MAUDE Adverse Event Report: B. BRAUN MEDICAL INDUSTRIES SDN INTROCAN WINGED PERIPHERAL INTRAVENOUS CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 4253540-02

Device Problems Device Slipped (1584); Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2022

Event Type  malfunction  

Event Description

B.Braun peripheral iv catheters.When removing from the package and then the clear plastic cap from the catheter the catheter slides partially off the needle and when the user tries to use the catheter the needle sheers the catheter from force against the patient skin.The peripheral catheter does not stay firmly on the needle until inserted in the skin.If the user pushes the catheter back on the needle a needle stick injury could occur or the peripheral catheter could sheer off.If the user does not realize the catheter is partially sheered, it could become emboli inside the patient vein.Effected products are all the b.Braun peripheral insertion catheters.The insyte brand catheter was previously used and safer for health professionals and patients because its catheter stays firmly on the needle until it is deployed inside the patient's vein.Fda safety report id # (b)(6).

• Brand Name: INTROCAN WINGED PERIPHERAL INTRAVENOUS CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MEDICAL INDUSTRIES SDN
• MDR Report Key: 14601895
• MDR Text Key: 293522235
• Report Number: MW5110114
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4253540-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American