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

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up report will be provided after the inspection results are available.

Event Description

As reported by the user facility ((b)(4): broken/ capillary.

Manufacturer Narrative

Exemption number e2016018.(b)(4).This report has been identified as b.Braun (b)(4) internal report # (b)(4).We received only one used capillary and one cannula of a introcan safety pur 18g, 1.3x45mm-sa without package.The returned capillary and the cannula were checked visually.The capillary was penetrated by the cannula approximately 13 mm away from the capillary tip.The area of the puncture shows a v-shaped damage.We assume that this puncture was caused by the introcan cannula by withdrawing and pushing forward again.According to this damage we assume an application problem and consider the complaint as not confirmed.Unable to review the device history records as the provided batch number has no values in our system.

• 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: 6777849
• MDR Text Key: 82187922
• Report Number: 9610825-2017-00163
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4251679-04
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2018
• Date Manufacturer Received: 07/13/2017
• 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