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

Model Number	4251890-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) used sample and a photo were provided for evaluation.The broken area of the returned catheter exhibited a "v" shape.This "v" shape is consistent with the needle piercing the catheter after being withdrawn and reinserted into the catheter.The ifu indicates, "after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off." if additional pertinent information becomes available a follow-up report will be filed.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the device involved in the reported event are being made.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility through medwatch (b)(4): the patient was brought to the operating room and laid supine on the operating table.After adequate general anesthesia was obtained, the right shoulder was prepped and draped in the usual sterile fashion.A small incision was made and a large amount of purulent material was then evacuated.There does appear to be extension down to the shoulder joint just on manual palpation with the suction device.Fluid was sent for culture.At this time, the patient went into cardiac arrest with ventricular fibrillation.Acls protocol was initiated with eventual return of spontaneous pulses as well as respirations; however, i did not place a drain.I merely quickly closed the small incision due to the ongoing need for chest compressions and resuscitation.The patient was taken to the icu in critical condition.During the resuscitation of the patient on the aforementioned incident, the b.Braun medical inc.Introcan fep straight safety iv catheter 14 ga x 1.25 in broke inside the patient's av fistula where the hub meets the catheter shaft.The broken end was not retrieved at the time due to the patient's critical condition.It is presumed that it migrated to the pulmonary vasculature.Additional information received from the user facility: a doctor was placing the catheter after the patient began coding.Doctors do not routinely place iv's at the facility.The malfunction occurred during placement and the staff were never able to use the catheter.The patient actually recovered and ended up being discharged home.We did not do anything to retrieve the catheter, not even an x-ray.He did not have any symptoms related to the missing catheter.

• Brand Name: INTROCAN SAFETY
• Common Device Name: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 10507090
• Report Number: 9610825-2020-00199
• Device Sequence Number: 3033717
• Product Code: FOZ
• UDI-Device Identifier: 04046963318154
• UDI-Public: (01)04046963318154
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4251890-02
• Device Catalogue Number: 4251890-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1