MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 4252500-02

Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Inventory of 5 introcan safety iv (intravenous) catheter 24g needle is bent inside the sealed package upon delivery.Unable to use due to defect.The four other needles that were defected were discarded in a sharp¿s container.One defective needle saved to be returned to manufacturer for evaluation.Reference reports: mw5117137, mw5117138, mw5117139, mw5117140.

• Brand Name: INTROCAN SAFETY IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 16843505
• MDR Text Key: 314491129
• Report Number: MW5117141
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4252500-02
• Device Catalogue Number: 4252500-02
• Device Lot Number: 22M02G8302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose