MAUDE Adverse Event Report: B.BRAUN MELSUNGEN AG INTROCAN SAFETY; IV CANNULAE

Catalog Number 4253574-02

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has not been received yet and the investigation is on going at this time.A follow up report will be provided when the results of the evaluation become available.

Event Description

As reported by the user facility: reports clip did not deploy.Occurred in er.

Manufacturer Narrative

(b)(4).Received five pieces reference sample of introcan safety-w pur 20g,1.1x25mm-us in open packaging.Lot number printed on returned packages were 16a28g8316 and material#4253574-02.Actual complaint sample was not returned for evaluation.All five pieces that were returned were functionally tested and passed the clip functional test.The clip engaged properly onto the tip of cannula.The cause of the reported defect could not be determine.Therefore, based on all the evaluations, and review of the device history records (dhrs) no abnormalities were found in the dhrs, this complaint is conclude as non-judgeable.In addition, a historical review of the complaint database identified no adverse trends for product code 4253574-02 or lot number involved.

• Brand Name: INTROCAN SAFETY
• Type of Device: IV CANNULAE
• 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 ; carl-braun-strasse 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5637999
• MDR Text Key: 44689263
• Report Number: 9610825-2016-00281
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2016,05/02/2016

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: 01/01/2021
• Device Catalogue Number: 4253574-02
• Device Lot Number: 16A28G8316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2016
• Distributor Facility Aware Date: 05/02/2016
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2016
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1