MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY; I. V. SAFETY CATHETER

Catalog Number 4251128-02

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One sample and photographs were received and all available information was forwarded to the manufacturer b.Braun malaysia.Statement from manufacturer: received one (1) used introcan safety 3-w pur 22g 0.9x25mm without packaging.The cannula hub and protective cap were not returned.A visual inspection observed the capillary was slightly bent; however, this is not determined to be a defect.In addition there were no kinks that were observed along the capillary.A review of the device history record for the lot was not performed due to the aforementioned lot number being unknown.Based on the results of the investigation, the manufacturer found no deviation on the returned sample.If additional pertinent information becomes available, a follow up report will be submitted.

Event Description

As reported by the facility: the customer reported that the catheter of the introcan safety 3 continues to bend and spike the pressure settings and or blow veins in patients.No patient injury.

• Brand Name: INTROCAN SAFETY
• Type of Device: I. V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str. 1; melsungen, D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 5496055
• MDR Text Key: 40207549
• Report Number: 9610825-2016-00110
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/11/2016,02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4251128-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2016
• Distributor Facility Aware Date: 02/11/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2016
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1