MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY; CATHETER,INTRAVASCULAR,THE

Catalog Number 4253566-03

Device Problem Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device history record (dhr): reviewed the device history record for batch number 19d14g8261 and there were no defect encountered during in process and final control inspection.Summary of root cause analysis: one used cannula of introcan safety-w pur 20g, 1.1x32mm-ap without packaging was received.Protective cap and catheter hub were not returned for evaluation.During visual inspection, no any dent mark or abnormality has been observed from the cannula surface of all cannula orientation and observed that the safety clip was dislodged.Review of device history record for complaint batch shows no abnormality.Final control visual inspection and safety clip functional test results for complaint batch were reported as passed.Safety clip dislodged is able to be simulated during cannula withdrawal in extreme angle and with faster speed.The simulation results are consistent with the complaint defect.According to ifu, during application user should remove the cannula by pulling cannula straight back with a controlled, continuous motion parallel to the skin and the cannula is advisable to be disposed of immediately into the sharps container.Therefore, root cause could not be determined.Clip dislodged most likely not appear to be attributed by the manufacturing process as our assembly machines are equipped with 100% inspection by the vision systems for the clip on all parts is available at assembly machine, it is unlikely that the defect escape from process.Along the whole manufacturing process, there are no interference/ contact between clip hole and cannula crimping area.Safety clip dislodged is able to be simulated by withdrawing the cannula in certain angle which is not following ifu.This report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility ((b)(4): the safety clip did not wrap the needle, which resulted in a needlestick for the nurse.

• Brand Name: INTROCAN SAFETY
• Type of Device: CATHETER,INTRAVASCULAR,THE
• 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, ; GM
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 11170441
• MDR Text Key: 226837706
• Report Number: 9610825-2020-00367
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: 4253566-03
• Device Lot Number: 19D14G8261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2020
• 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
• Patient Outcome(s): Other