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

Model Number	N/A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016018 b.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun melsungen ag internal report # (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see instruction for use: never reinsert the needle inside the catheter once the needle has been partially or completely withdrawn as it may pierce and/or sever the catheter).Consequently, we consider the complaint not confirmed.Device history record review (dhr) :- reviewed the device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 or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in united kingdom): plastic tube which sits in vein snapped.

• Brand Name: INTROCAN® SAFETY
• Common Device Name: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 6525906
• Report Number: 9610825-2017-00088
• Device Sequence Number: 13867778
• Product Code: DQR
• UDI-Device Identifier: 04046964014055
• UDI-Public: (01)04046964014055(17)211001(10)16L06G8375
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K982805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2017
• Report Date (Section F): 04/27/2017

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
• Operator of Device: 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
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/27/2017