MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY 3; CATHETER,INTRAVASCULAR

Catalog Number 4251127-03

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/02/2021

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4): device history record (dhr): reviewed the device history record for batch number 20h27g8372 and there were no defect encountered during in process and final control inspection.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 (b)(6): catheter was damaged."complaint: it is used for patients with dementia, and it was confirmed that the indwelling needle was pulled out during the round.However, the catheter part was not found.The customer searched for the catheter part by ct scan etc., but could not find it.At the time of the event, there are traces that the patient was playing with the infusion route, and it seems that the patient is self-removing, but it is a request to check the condition of the product.Please check the ruptured part.".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).Received 1 used and contaminated introcan safety 3 pur 24g 0.7x19mm-ap without packaging.Summary of root cause analysis: received 1 used capillary hub of introcan safety 3 pur 24g 0.7x19mm without packaging, cannula hub and protective cap was not returned for investigation.The sample was taken for investigation and observed the capillary was tear off at capillary horn.The broken area was uneven and deformed from its original shape.From the complaint description, it was reported patient seemed to remove the catheter by him/her self.Cause: defect due to wrong handling (referring to application error or off-label use) 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.Torn off capillary defect most likely not appear to be attributed by manufacturing process as the defect is able to be detected by the in-line vision system.Damages induced after assembly process is not possible since the catheter had been protected with the protective cap.It was reported patient seemed to remove it by him/her self.Furthermore, the complaint sample is a used product and no further investigation can be conducted and the exact cause of the failure could not be determined.Justification: not confirmed.

• Brand Name: INTROCAN SAFETY 3
• Type of Device: CATHETER,INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 11779927
• MDR Text Key: 264412529
• Report Number: 9610825-2021-00160
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4251127-03
• Device Lot Number: 20H27G8372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention