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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/20/2020

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).No sample has been returned for investigation.Device history record (dhr): the complaint reported article was unknown with batch no 19d30g8391.Checked in sap mya and the article is 4253523-03-pcn for batch 19d30g8391.Reviewed the dhr of the complaint batch 19d30g8391 and no abnormality observed during in process and at final control inspection.Problem analysis: the situation described in the description probably referring to catheter was tear off/broken off.However, there was no further information on method of handling the product.The actual sample or picture of the event was not able to be retrieved to confirm the reported defect.Review of manufacturing process: the introcan safety is assembled on automated assembly machine equipped with vision systems and test stations.All the in-line test equipment is subject of a frequent calibration and a regular verification related to its proper function.Herewith, potential malfunctions of the systems would be detected in time and would be mitigated immediately.Possible root cause: there is possibility that the catheter could be cut off as communicated in ifu: warning section stated that: after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off, leading to catheter embolism.Do not bend the catheter/needle during insertion, advancement, or removal of the needle.Extreme care should be taken not to cut the catheter and possibly cause an embolism.Simulation activity: we simulated a fresh sample by purposely cut off the catheter to 14.02mm in length.When the simulated sample went through the vision system, it was rejected because it could not detect the catheter tip as the length was too short.The simulated was automatically rejected by machine.Conclusion: damaged catheter-tear off/broken most likely not appear to be attributed by the manufacturing process as the defect is able to be detected and rejected by the in-line vision systems of the equipment.Damages induced after assembly process is not possible since the catheter has been protected with the protective cap.Complaint is not confirmed.Note: this report is being filed for an item number that is not sold in the united states, however this item or similar items are sold in the united sates by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): cancula was broken on (b)(6) 2020, at 13:00, the nurse inserted indwelling needle for the child.Before the puncture, the external cancula of the indwelling needle was complete and the puncture process was smooth.Infusion treatment was carried out in the day and night on the same day, and the treatment was successfully completed, and the tube sealing was unobstructed without abnormality.On (b)(6) 2020, at 10:33 the nurse was ready to infuse for the child.After connecting the infusion connector and opening the regulator, it was found that there was liquid outflow around the application.The regulator was closed immediately.There was no redness or swelling around the puncture site, and the child did not feel pain.It was preliminarily determined that the cancula of indwelling needle was blurt out and the indwelling needle was to be pulled out.After removing the adhesive tape, the nurse found that the remaining cancula was 0.6cm (the original length of the external cancula of the indwelling needle was 1.9cm).There was no blood oozing and fluid at the puncture site.No broken indwelling needle cancula was found in bed unit, ground and application.It was suspected that the cancula was broken in the blood vessel.After checking by the doctor, the patient was asked to lie flat, brake her right hand, monitor her upper heart electricity, change the second level nursing to the first level nursing, and closely observed the vital signs and changed of her condition.Consulted with the vascular and thyroid surgery.B-ultrasonic examination of the vein of the upper limbs beside the bed and dr examination of the right wrist and elbow joints beside the bed were performed.

• Brand Name: INTROCAN SAFETY
• Type of Device: I.V. SAFETY CATHETER
• 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, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon boulevard; allentown, pa ; 2408332
• MDR Report Key: 10176165
• MDR Text Key: 196278761
• Report Number: 9610825-2020-00118
• Device Sequence Number: 1
• Product Code: DQR
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• 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 Model Number: N/A
• Device Catalogue Number: 4253523-03-PCN
• Device Lot Number: 19D30G8391
• 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: 06/19/2020
• Date Report to Manufacturer: 06/19/2020
• Date Manufacturer Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• 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): Required Intervention