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

Catalog Number 4251628-04

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

As reported by the user facility ((b)(4)): according to the customer: "catheter needle with the security device not lock, bent and out of the catheter.".

Manufacturer Narrative

(b)(4).The device is currently shipping from (b)(6) to (b)(4) for investigation.A f/u report will be provided when the inspection results become available.(b)(4).

Manufacturer Narrative

(b)(4).We received one used introcan safety pur 22g, 0.9x25mm-sa in open packaging.The received sample was visually examined.In 'as-received' condition, the safety clip was properly activated on the tip of the cannula.Furthermore the raw cannula was slightly bent.The safety clip was taken to a functional test (sliding the safety clip on the raw cannula).It was easily possible to slide the safety clip on the raw cannula and to fix the clip on the tip of the cannula.The special feature of a self-activating safety clip that automatically covers the needles sharp bevel was given.The used sample is within specifications.We have informed our manufacturer accordingly.Reviewed the device history record and there were no defect encountered during in-process and final control inspection.Process cards also show no abnormalities.

• Brand Name: INTROCAN SAFETY
• Type of Device: IV SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4586545
• MDR Text Key: 15321686
• Report Number: 9610825-2015-00069
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/17/2015,02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: 4251628-04
• Device Lot Number: 14G01G8301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2015
• Distributor Facility Aware Date: 03/02/2015
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2015
• Date Manufacturer Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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