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

Catalog Number 4251644-02

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

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Date 06/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual sample has been received and the investigation is on going at this time.A follow up report will be submitted when the results of the investigation become available.

Event Description

As reported by the user facility: event 1: when the nurse (who was not trained on the product) was unsuccessful and she removed the needle but did not activate the safety shield by removing the stylet and stuck herself, user error.

Manufacturer Narrative

(b)(4).The samples and all available information were forwarded to the manufacturer for further evaluation.Their report states that they received 6 used cannula hub of introcan safety and 1 used capillary hub of introcan safety without packaging.These samples were contained in one small plastic container the returned cannulas were noted to be bent about 10 degrees to 30 degrees, possibly due to the transportation in the small container.The samples were visually inspected and it was noted on one of the returned cannula that the safety clip was located at the middle of the cannula and not in an engaged position.Investigation results: the used samples were straightened and checked by repositioning the clip and retesting its function by using the returned catheter hub (g20) and placing it onto the cannula.The clips engaged properly onto the tip of the cannula.There was no abnormality found while pulling the catheter out from the cannula.There was no rough surface/dented mark observed on cannula surface.The device history record was reviewed and there were no such defect encountered during in-process and final control inspection.Process cards show no abnormalities.Conclusion: during clip functionality test with the returned catheters, there was no defect/damage found on the clip after pulling it out from the cannula.There was only one catheter hub returned for the used sample.Therefore, the complaint is not judgable.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, 34212 ; GM 34212
• Manufacturer (Section G): B.BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-strasse 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 4929220
• MDR Text Key: 22592161
• Report Number: 9610825-2015-00265
• Device Sequence Number: 0
• Product Code: FOZ
• 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
• Report Date: 08/25/2015,06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 4251644-02
• Device Lot Number: 15C18G8393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2015
• Distributor Facility Aware Date: 06/30/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2015
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2015
• 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