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

Catalog Number 4251628-01

Device Problems Break (1069); Device Handling Problem (3265)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/03/2014

Event Type  Injury  

Event Description

As reported by the user facility (translation of user facility info by bbm sales organization in (b)(4)): break of the peripheral intravenous catheter when it was removed, and a part of the device remained into the vein, which obliged a surgery to perform debridement and removal of the catheter.

Manufacturer Narrative

(b)(4).We received one used capillary housing with capillary of an introcan safety pur 22g, 0.9x25mm-eu in open packaging (only paper foil was assigned by the customer).The received sample was taken to a visual examination.The introcan needle was not provided by the customer, we received only the capillary housing with capillary, connected with a reflux valve.At the received sample the capillary was torn off approx 1 mm away from the capillary housing.An uneven structure was visible at the capillary in the area of the damage.The torn-off part with the capillary tip was not provided by the customer.We exclude a production problem and assume that the capillary was torn off during the application; therefore, we assume an application error and consider the complaint as not justified.We have informed our mfr accordingly.Reviewed the device history record and there was no defect encountered during in-process inspection and at final control inspection.The process cards also show no abnormalities.(b)(4).

• Brand Name: INTROCAN SAFETY
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen 3421 2; GM 34212
• Manufacturer Contact: ludwig schuetz, safety officer ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4001280
• MDR Text Key: 4688731
• Report Number: 9610825-2014-00284
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: 4251628-01
• Device Lot Number: 4B08258394
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2014
• Distributor Facility Aware Date: 07/08/2014
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2014
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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
• Patient Outcome(s): Other