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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT,4FR POWERMIDLINE; MIDLINE CATHETER
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BARD ACCESS SYSTEMS DOT,4FR POWERMIDLINE; MIDLINE CATHETER Back to Search Results
Model Number N/A
Device Problem Misassembled (1398)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redp4273 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that midline lumen was not properly threaded through clamp.It was stated because of this, the lumen was not able to be clamped correctly, this resulted in midline having to be exchanged over guide wire.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the extension leg could not be clamped properly was confirmed to be manufacturing related.One 4 fr powermidline catheter was returned for investigation.A sticker label with product information ref: f4154108 and lot: redp4273 was also returned.The catheter was trimmed between the 2 and 3 cm depth marker.The clamp on the extension tubing was found to have been misassembled.The extension tubing did not pass through the second section of the clamp.Since the issue appears to be manufacturing related, the complaint is confirmed.
 
Event Description
It was reported that midline lumen was not properly threaded through clamp.It was stated because of this, the lumen was not able to be clamped correctly, this resulted in midline having to be exchanged over guide wire.
 
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Brand Name
DOT,4FR POWERMIDLINE
Type of Device
MIDLINE CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8951898
MDR Text Key156403163
Report Number3006260740-2019-02568
Device Sequence Number1
Product Code PND
UDI-Device Identifier00801741108754
UDI-Public(01)00801741108754
Combination Product (y/n)N
PMA/PMN Number
K153393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberP4154108
Device Lot NumberREDP4273
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2019
Event Location Hospital
Date Manufacturer Received09/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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