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

Catalog Number 4253523-03

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Summary of root cause analysis: received 2 picture of 2pcs capillary hub of introcan safety-w pur 24g, 0.7x19mm-ap and 1 empty peel pack.From the picture received 1 capillary hub was used sample while the others one seems like unused sample.From the comparison the used capillary hub have shorter length of the capillary compare to the unused capillary.The cut off part of capillary cannot be seen in the picture.The surface of the torn off areas was not visible on the 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.Cut 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.Since no defect samples provided, no further investigation can be carried out thus this complaint will be concluded as not confirmed.Reviewed the device history record and no abnormalities found during in process and final control inspection.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)): broken capillary.It was suspected that the broken tube was in the blood vessel.No broken tube was found by ultrasound or x-ray examination.

• Brand Name: INTROCAN SAFETY
• Type of Device: INTRODUCER, 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 blvd.; allentown, pa ; 2408332
• MDR Report Key: 10065527
• MDR Text Key: 191264752
• Report Number: 9610825-2020-00108
• Device Sequence Number: 1
• Product Code: DYB
• 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: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• 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 Catalogue Number: 4253523-03
• Device Lot Number: 19D30G8391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2020
• 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
• Patient Age: 10 YR