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

Model Number	4252519-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the device involved in the reported incident are being made.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported on mw (b)(4): 22g iv catheter broke upon attempted iv removal.The clear catheter portion broke apart from the blue hub.The patient was taken to the ir lab for retained foreign body retrieval.The foreign body was removed completely.Bedside rn removed dressing on rt forearm piv to assess leaking, noted that hub broke off from catheter, and catheter appears to be retained in the body.Rn called vad to assess.Vad asked rn to apply tourniquet to rt upper arm, immediately came to bedside.Pt is calm, no distress.Vad can see catheter fragment on us retained in lower rt forearm cephalic vein, i marked location with sterile skin pen.This vad rn remained at bedside, continuously monitoring pt, kept tourniquet on rt upper arm, applied hand tourniquet to upper forearm, periodically checked that catheter piece remained in same place on us, ensured that pt kept rt arm still/relaxed and did not get out of bed, had pt call her mom so i could update her and ask her to come back to the hospital.Covering mds (intern, fellow, attending) came to bedside to assess and update, state ir team will come in emergently to remove catheter fragment.This vad rn remained at bedside continuously monitoring pt until or was ready, also transporting pt to pre op and given report to ir doctor, until pt wheeled to operating room by physicians.Pt remained calm with no distress.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: INTROCAN SAFETY
• Common Device Name: CATHETER,INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 11446757
• Report Number: 9610825-2021-00067
• Device Sequence Number: 3523411
• Product Code: FOZ
• UDI-Device Identifier: 04046963165949
• UDI-Public: (01)04046963165949
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K020785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: 4252519-02
• Device Catalogue Number: 4252519-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR