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

Model Number N/A

Device Problem Chemical Problem (2893)

Patient Problem Phlebitis (2004)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device has not been received yet and the investigation is on going at this time.A follow up report will be submitted when the investigation results become available.

Event Description

As reported by the user facility: customer reports that chemical phlebitis is occurring.This is occurring with medications such as taxotere, taxol, cistplatin, adromycin.Customer verbalizes that this has been occurring for the past couple of months, and when they use nexiva brand, this does not occur.

Manufacturer Narrative

(b)(4).The samples and all available information were forwarded to the manufacturer for further evaluation.Their report states that they received 2 introcan safety 3-w pur 22g 0.9x25mm-us in original packaging.Lot number printed on the returned packages were 15e18g8371 and material# 4251128-02.Visually inspected the returned samples and found no abnormalities.Cytotoxicity test requires a minimum of 50 pcs of samples, hence, no test can be performed on the two samples returned.The test conducted during the development of introcan safety 3 shows that the product complies with (b)(4).Device history record (dhr): reviewed the device history record and there were no defect encountered during in-process or final control inspection.Process cards also show no abnormalities.Sterility test information: process sterilization process sterilization reviewed and found no discrepancy or deviation.All parameter are within specification.Bi sterility: bi sterility result reviewed and found all results are within the specification.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the event.If additional pertinent information becomes available, a follow up report will be submitted.

• Brand Name: INTROCAN® SAFETY
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5155043
• MDR Text Key: 28437080
• Report Number: 9610825-2015-00451
• 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: Other Health Care Professional
• Type of Report: Followup
• Report Date: 11/24/2015,10/01/2015

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 Expiration Date: 05/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 4251128-02
• Device Lot Number: 15E18G8371
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/24/2015
• Distributor Facility Aware Date: 10/01/2015
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2015
• 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