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

Catalog Number 4251601-03

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Patient Involvement (2645)

Event Date 07/18/2014

Event Type  malfunction  

Event Description

As reported by the user facility (translation of user facility info by bbm sales organization in (b)(4)): the safety shield didn't automatically cover the needle tip as withdraw needle exited the catheter hub.

Manufacturer Narrative

(b)(4).B.Braun med, inc.(importer) is submitting this report on behalf of b.Braun (b)(4) (mfr).This report has been identified as (b)(4).Received one cannula of introcan safety pur 24g, 0.7x19mm-ap without packaging.The capillary hub and protective cap was not returned for evaluation.Visually inspected the returned sample and found that the safety clip was located at approximately 5mm from the cannula's tip (not in engaged position).Reviewed the device history record and there were no such defect encountered during in-process and final control inspection.Process cards show no abnormalities.Sample forwarded to production for further investigation.A follow-up report will be provided after the inspection results are available.

• Brand Name: INTROCAN SAFETY
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen 3421 2; GM 34212
• Manufacturer Contact: ludwig schuetz, safety officer ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4071950
• MDR Text Key: 16544907
• Report Number: 9610825-2014-00323
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/26/2014,07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: 4251601-03
• Device Lot Number: 4B25258391
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2014
• Distributor Facility Aware Date: 07/28/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2014
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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