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

Model Number N/A

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

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(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: reports introcan safety catheter that was used and clip is deployed 1/2 way down needle, not on end.Nurse did have needle stick.Rn placed cath with no problems stated withdrew needle in normal manner (started to withdraw slowly once free removed in one steady motion).Placed needle down on chux to secure iv cath - went to clean up picking up chux when injury occurred.Rn stated they did nothing to have caused the clip to move back up the needle so thinking clip did not deploy over tip of needle.After event i did note there appeared to be a very slight bow in the needle - this could have occurred after the event.Rn was sent to our er and followed our needle sick protocol - pt blood tested, employee (b)(6) to follow.

Manufacturer Narrative

(b)(4).Received one used introcan safety without packaging.The safety clip for returned sample was not in engaged position and clip was not deform.Protective cap and catheter hub was not returned for evaluation.The returned cannula od is 0.705mm and it was identified as g20.The returned sample was checked by repositioning the clip and retesting its function by using new catheter hub (g20) and placing it onto the cannula and then pulling it and found that the clip engaged properly onto the tip of the cannula.There was no abnormality found while pulling the catheter out from the cannula.The clip engaged properly onto the tip of the cannula.There was no rough surface/dented mark observed on cannula surface.During clip functionality test with a new catheter hub, there was no defect/damage found on the clip after pulling it out from the cannula.Also, the clip engages properly onto the tip of the cannula.There was no rough surface/dented mark observed on cannula surface.There was no clip deformation.Cause could not be determine there was no catheter hub returned for further evaluation.Unable to review the device history record as it is an unknown batch number.This complaint is conclude as non-judgeable.As this is a used sample and the item and lot number were reported as unknown, further investigation of the complaint is not possible and no specific conclusion could be drawn as to the cause of the reported event.Justification: not judgeable multiple attempts to obtain item, lot number and further information were not successful.If additional pertinent information becomes available, 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 ; carl-braun-strasse 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5638024
• MDR Text Key: 44689616
• Report Number: 9610825-2016-00237
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2016,04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2016
• Distributor Facility Aware Date: 04/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2016
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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