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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received one used capillary housing of an introcan safety 3-w pur 20g 1.1x32mm-eu in open packaging.The needle inclusive housing was not handed over by the customer.The returned sample was taken to a visual inspection.The capillary is cut off approximately 10 mm away from the capillary housing.The cut off portion is missing and was not delivered by the customer.The cut-off point of the capillary shows the typical v-shaped cut (e.G.If damaged by the tip of the needle).We assume that this puncture / cut off was caused by withdrawing the introcan cannula and pushing forward again.According to the damage at the used sample we assume of an application error (application error; see instruction for use: never reinsert the needle inside the catheter once the needle has been partially or completely withdrawn as it may pierce and/or sever the catheter).Consequently, we consider the complaint not confirmed.Device history record review (dhr) : reviewed the device history record and no abnormalities found during in process and final control inspection.

Event Description

As reported by the user facility ((b)(4)): plastic tube which sits in vein snapped.

• Brand Name: INTROCAN® SAFETY
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 200 boulder dr.; breinigsville, PA 18031 ; 4842408332
• MDR Report Key: 6525906
• MDR Text Key: 74040704
• Report Number: 9610825-2017-00088
• Device Sequence Number: 1
• Product Code: DQR
• UDI-Device Identifier: 04046964014055
• UDI-Public: (01)04046964014055(17)211001(10)16L06G8375
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2017,04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4251130-01
• Device Lot Number: 16L06G8375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2017
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2016
• 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