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

Catalog Number 4251652-02

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: customer reported safety clip did not deploy correctly to cover needle tip when removed from catheter.No injury.

Manufacturer Narrative

(b)(4).Investigation results: received one used (contaminated with blood) cannula hub of introcan safety pur 20g, 1.1x25mm-us in an opened packaging.The capillary hub and protective cap were not returned for investigation.Visually inspected the returned sample and observed the safety clip was located in the middle of the cannula, not in an engaged position.For functional test, the safety clip was repositioned and a new g20 catheter hub was placed onto the cannula.Upon withdrawal, the clip was able to engage and covered the tip of the cannula.There was no rough surface/dented mark observed on cannula surface.Clip was not deformed.The assembly machine is equipped with vision system which conducts 100% inspection on the clip condition.Therefore, it is unlikely a defective clip can escape the process.The catheter hub was not returned for further evaluation.A review of the device history record was performed and there were no such defect encountered during final control inspection.The cause of the reported defect could not determined.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available the complaint will be re-opened and a follow up 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, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun str.1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; b. braun melsungen ag; carl-braun str. 1; melsungen, 34212 ; GM 34212 ; 661712769
• MDR Report Key: 6169282
• MDR Text Key: 62609144
• Report Number: 9610825-2016-00888
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046963185206
• UDI-Public: (01)04046963185206(17)210401(10)16D16G8391
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2017,11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 4251652-02
• Device Lot Number: 16D16G8391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2017
• Distributor Facility Aware Date: 11/29/2016
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2017
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/16/2016
• 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