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

Model Number 4251601-020

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/27/2022

Event Type  Injury  

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in australia: "tip of catheter remained in vein." "we have had an incident involving one of the bbraun cannulas we use (24g introcan safety cannula).On removal of the cannula post unsuccessful cannulation it was noted that part of the tip of the cannula was missing.The patient was sent for ultrasound given the thrombus risk if some of the cannula had broken off and on ultrasound it was identified that the tip of the cannula remained in the vein.The patient had to have vascular review and surgery which was performed over the weekend to remove the cannula piece from her vein.Customer does not know the lot number but there are two batches available: 22c24g8315 and 22c22g8316.".

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).The complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.Note: 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.

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).Summary of root cause analysis: received 1picture of used introcan safety pur 24g, 0.7x19mm-ap.Based on the picture received, the cannula has not been withdrawn and the safety clip is still inside the catheter hub.The capillary was filled with blood which confirmed secondary flash back and it is observed that the capillary tip had broken off.It is reported the other part of the capillary had remained in patient's vein.Based on the picture receive the area of the broken capillary was not clear.Since no sample have been returned the investigation will be based on the receive picture.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.Beside the automated 100% in-line test equipment, independent in-process quality controls and final controls on a random sample basis will be conducted by different teams on a regular basis within the production process.Herewith a systematic product defect would be detected.Tear off capillary most likely not appear to be attributed by manufacturing process as the defect is able to be detected and reject by the in-line vision system.Damages induced after assembly process is not possible since the catheter had been protected with protective cap.The actual sample involved in the event was not available for evaluation.Without the actual sample and due to low image quality, the detailed defect feature was unable to be determined.Hence, this complaint will be concluded as not confirmed 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.Device history record (dhr): complaint batch is unknown but provided two batch numbers 22c24g8315 22c22g8316 now in the facility inventory for g24.Reviewed the dhr of the possible batch 22c24g8315/4251601-03 and 22c22g8316/4251601-03, no abnormality observed during in-process and at final control inspection.Note: 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.

• 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
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15681845
• MDR Text Key: 302504406
• Report Number: 9610825-2020-00444
• Device Sequence Number: 1
• Product Code: DQR
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250501(10)20E06G8911
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4251601-020
• Device Catalogue Number: 4251601-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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