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

Catalog Number 4254503-02

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

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

As reported by the user facility: event: customer reports, needle stick injury.The nurse started the iv, while holding onto the wings to tread needle.When the nurse went to pull out the needle there was resistance, so the nurse pulled a little harder.The needle popped out without activating the safety mechanism, the needle bounced back into nurses left pointer finger about 1/4 inch in (pressure was applied to bleeding).Upon inspection to needle faulty safety mechanism is stuck above needle tip.The nurse and pt boh had labs drawn.Results of labs work were within normal limits.

Manufacturer Narrative

(b)(4).The actual device has not been rec'd and the investigation is ongoing at this time.A f/u will be submitted when the investigation results become available.(b)(4).

Manufacturer Narrative

(b)(4).The sample and all available information was forwarded to the manufacturer for further evaluation.Their report states that they received 1 used (contaminated with blood) cannula of introcan safety- w fep 24g, 0.7x19mm-us without packaging.One protective cap which does not belong to introcan safety was also received.The capillary hub was not returned for evaluation.The returned sample was visually inspected and found that the safety clip was located below the crimping area of the needle and not in an engaged position.It was further observed that there was a flat surface impact on the cannula.Dent on the cannula is about 13.90 to 15.10 mm from needle's tip.The exact similar defect could not be replicated.It is possible that a worn out cannula magazine could lead to a dent on the cannula body.Preventive action has taken place to address this matter where cannula magazine replacement was done on the manufacturing machines.However, without the lot number and cap, further evaluation was not possible.No adverse trends of this nature were identified during the complaint review process for product code #(b)(4).If additional pertinent information becomes available, a follow up report will be submitted.

• Brand Name: INTROCAN SAFETY
• Type of Device: IV 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: 4649142
• MDR Text Key: 20786716
• Report Number: 9610825-2015-00088
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2015,03/06/2015

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: Health Professional
• Device Catalogue Number: 4254503-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2015
• Distributor Facility Aware Date: 03/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2015
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 03/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/18/2015
• 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