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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD POWERMIDLINE CATHETER BASIC KIT 4F SL 20 CM
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BARD POWERMIDLINE CATHETER BASIC KIT 4F SL 20 CM Back to Search Results
Model Number N/A
Device Problem Fluid/Blood Leak (1250)
Patient Problems Air Embolism (1697); Coma (2417); Confusion/ Disorientation (2553)
Event Date 05/24/2021
Event Type  Injury  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that on 05/20, a patient was transferred to a different facility for cardiac decompensation.Since 05/22, the patient presented episodes of mild confusion when no history of cognitive impairment was known.Night from 05/24 to 05/25, the patient's state of consciousness deteriorates again.Within hours, the patient is became comatose and aphasic.A brain scan finds the presence of air embolism.A midline had been laid in facility on 05/12.During the night of 05/24 to 05/25, trying to inject 10 cc of physiological serum under certain pressure, the ide notices that there is a flow between the purple part of the midline and the orange part (the valve).The midline is directly withdrawn and a bubble is observed at the level of the bidirectional valve.No anomalies had been noted on the midline before this date.In addition, a cardiac catheter was put in place on 05/21 with the aim of to perform a coronary angiography.This catheter was removed immediately after the coronary angiography.Current state of the patient: cerebral air embolism, with clinical consequences of aphasia and comatose state with a glasgow score rated at 7-8.The patient was urgently intubated and faced with hemodynamic failure, a noradrenaline treatment was started.Actions taken in the care establishment for the care of the patient: actions for the patient: regarding the midline, it was removed (along with the valve and the stopcock) by the ide immediately after it found a flow between the purple part of the midline and the orange part (the valve) concerning the cardiac catheter, it has been removed just after the coronary angiography.
 
Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), labeling, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak in the catheter was inconclusive due to the sample condition.Two photographs of an explanted 4fr s/l powermidline catheter were returned for evaluation of this complaint.The catheter¿s luer adaptor was attached to a needleless injection cap, which was not included in the catheter kit.The needleless injection cap was attached to a 3-way stopcock.A black arrow was drawn on the photos pointing to the needleless injection cap with an orange valve.As per the event description, ¿there is a flow between the purple part of the midline and the orange part (the valve).¿ the threads of the catheter appeared to be fully engaged with the threads of the needleless injection cap.No obvious cracks, splits or holes were visible in any part of the catheter.Without the physical sample, complete visual examination, microscopic evaluation, functional testing, dimensional analysis, and/or tactile evaluation could not be completed.As the source of the leak was not apparent in the photographs, the complaint that the power midline caused or contributed to the reported event was inconclusive.Possible contributing factors could include damaged injection cap, sharp instrument damage, over-pressurization, damaged connector, or an incomplete or incompatible connection with an auxiliary device.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.
 
Event Description
It was reported that on 05/20, a patient was transferred to a different facility for cardiac decompensation.Since 05/22, the patient presented episodes of mild confusion when no history of cognitive impairment was known.Night from 05/24 to 05/25, the patient's state of consciousness deteriorates again.Within hours, the patient is became comatose and aphasic.A brain scan finds the presence of air embolism.A midline had been laid in facility on 05/12.During the night of 05/24 to 05/25, trying to inject 10 cc of physiological serum under certain pressure, the ide notices that there is a flow between the purple part of the midline and the orange part (the valve).The midline is directly withdrawn and a bubble is observed at the level of the bidirectional valve.No anomalies had been noted on the midline before this date.In addition, a cardiac catheter was put in place on 05/21 with the aim of to perform a coronary angiography.This catheter was removed immediately after the coronary angiography.Current state of the patient: cerebral air embolism, with clinical consequences of aphasia and comatose state with a glasgow score rated at 7-8.The patient was urgently intubated and faced with hemodynamic failure, a noradrenaline treatment was started.Actions taken in the care establishment for the care of the patient: actions for the patient: regarding the midline, it was removed (along with the valve and the stopcock) by the ide immediately after it found a flow between the purple part of the midline and the orange part (the valve) concerning the cardiac catheter, it has been removed just after the coronary angiography.
 
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Brand Name
BARD POWERMIDLINE CATHETER BASIC KIT 4F SL 20 CM
Type of Device
MIDLINE CATHETER
MDR Report Key12183447
MDR Text Key262172183
Report Number3006260740-2021-02805
Device Sequence Number1
Product Code PND
Combination Product (y/n)N
PMA/PMN Number
K153393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberP6154118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2021
Date Manufacturer Received07/23/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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