MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; INTRODUCER, CATHETER

Model Number 4252500-02

Device Problem Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.Review of the device history record performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.If additional pertinent information becomes available a follow-up report will be filed.Note: it's indicated that we received two (2) medwatch reports, mw5082930 and mw5082912, however we did confirm with the end customer that report mw5082912 was a duplicate report and that only one (1) incident occurred.

Event Description

As reported by user facility: a nurse was starting an iv on a patient when the iv infiltrated.When she removed the catheter, the safety mechanism did not engage and the nurse had a needle stick in her index finger.

• Brand Name: INTROCAN SAFETY®
• Type of Device: INTRODUCER, 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, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4842408332
• MDR Report Key: 8374240
• MDR Text Key: 140148722
• Report Number: 9610825-2019-00028
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 04046963165963
• UDI-Public: (01)04046963165963
• 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: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2019

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: 07/01/2023
• Device Model Number: 4252500-02
• Device Catalogue Number: 4252500-02
• Device Lot Number: 18G17G8923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2019
• Distributor Facility Aware Date: 02/07/2019
• Device Age: 6 MO
• Event Location: Other
• Date Report to Manufacturer: 02/27/2019
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2018
• 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