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

Catalog Number 4252578-02

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was not returned for evaluation.Without the actual sample, a thorough investigation could not be performed.A historical review of the complaint database identified no adverse trends for product code 4252578-02 or possible lot numbers involved.A follow up report will be submitted when the investigation results become available.Not returned.

Event Description

As reported by the user facility: event description: customer reports, clip did not engage.No injury reported.Lot number was reported as unknown; however, possible lot numbers were provided.Possible lot numbers: 15c27g8271, 15c26g8274, 15e20g8291, 14h31g8233.

Manufacturer Narrative

(b)(4).Two (2) photos of the failed device were received; however, based on the pictures, the manufacture was unable to determine the cause of the incident.Multiple unsuccessful attempts were made to obtain a sample.No sample was returned for evaluation ; because of this, further investigation of the complaint is not possible and no conclusion could be drawn from the photos.Hence, the complaint is assessed to be not judgeable.A historical review of the complaint database identified no adverse trends for product code (b)(4) or possible lot numbers involved.If a sample and/or 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 ; b. braun melsungen ag; carl-braun str. 1; melsungen, 34212 ; GM 34212 ; 661712769
• MDR Report Key: 5263318
• MDR Text Key: 32585971
• Report Number: 9610825-2015-00583
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2016,11/19/2015

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: Nurse
• Device Catalogue Number: 4252578-02
• Device Lot Number: UNKNOWN
• 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: 02/05/2016
• Distributor Facility Aware Date: 11/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2016
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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