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 08/02/2022

Event Type  Injury  

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.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in australia: "catheter broken." "the registered nurse (rn) caring for patient was flushing the pivc with normal saline situated on her r) cubital fossa.Whilst flushing the pivc it was noted by the rn the dressing was wet and leaking from the pivc insertion site.The rn had stopped flushing the pivc and decided to remove the dressing to see why the pivc was leaking.When the dressing was removed it was observed that the 16g pivc hub/bung part was without the white plastic lumen.The rn looked through dressing to see if it was stuck to the dressing and then palpated the cannula site where she could feel the white plastic lumen still in the vein.The rn requested another nurse to re-examine and this was reported the treating team (tt) rmo who examined the site.The tt rmo advised for the dressing to be removed along with the detached hub and apply dots to the site for the surgical registrar to examine and ultrasound.Patient was booked in for exploration and removal of foreign body.".

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).Unable to review the device history record as batch is unknown.No sample received and no photo available for a proper analysis.All the products are subjected to in-process quality controls and final controls inspection on a random sample basis which has been conducted by different teams on a regular basis within the production process to ensure the product are free from any damages.Herewith a systematic product defect would be detected.As no sample received and batch is unknown, further evaluation was not possible.Complaint is not confirmed.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: 15442260
• MDR Text Key: 300092923
• Report Number: 9610825-2020-00379
• 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: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• 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: 4251133-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• 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