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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE ST MIDLINE CATHETER MAXIMAL BARRIER KIT (20G) (10CM)
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BARD ACCESS SYSTEMS POWERGLIDE ST MIDLINE CATHETER MAXIMAL BARRIER KIT (20G) (10CM) Back to Search Results
Model Number N/A
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/13/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redt4147 showed two other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the powerglide leaked at extension.The clinician took off extension and put on a different extension, left for an hour and came back to the bed and it was leaking.Took off extension and no crack in extension or hub that was noticed.The clinician said that it looks like there is a dent in the hub of catheter.Changed powerglide over wire.Changed extension and no issues or leaking.
 
Event Description
It was reported that the powerglide leaked at extension.The clinician took off extension and put on a different extension, left for an hour and came back to the bed and it was leaking.Took off extension and no crack in extension or hub that was noticed.The clinician said that it looks like there is a dent in the hub of catheter.Changed powerglide over wire.Changed extension and no issues or leaking.
 
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of leakage at the connection with the powerglide catheter was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 20ga x 10cm powerglide pro rt midline catheter.Slight curved shape memory was observed along the catheter shaft.Several depressions were observed in the luer adapter.The depressions appeared to cause irregularities in the luer threads.Microscopic inspection of the luer confirmed depressions in the molded part and irregular threads.Attempts to attach non-complainant luer-lock accessories resulted in loose connections.During infusion, leakage was observed emanating from the connection.The observed leakage at the connection to the luer adapter was caused by luer irregularities that appeared to have occurred during the molding process.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.Reynosa evaluation: complaint due to ¿there is a dent in the hub of catheter¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual, microscopical visual and functional testing performed by vad field assurance the following was concluded: the luer adapter of catheter was found to be deformed in the proximal end with threads damages causing the reported leakage.This condition was caused during the molding process and it makes the device unusable for our customer.Therefore, the cause of this condition is manufacturing related.A lot history review (lhr) of redt4147 showed two other similar product complaint(s) from this lot number.
 
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Brand Name
POWERGLIDE ST MIDLINE CATHETER MAXIMAL BARRIER KIT (20G) (10CM)
Type of Device
MIDLINE CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9789084
MDR Text Key194373742
Report Number3006260740-2020-00733
Device Sequence Number1
Product Code PND
UDI-Device Identifier00801741139376
UDI-Public(01)00801741139376
Combination Product (y/n)N
PMA/PMN Number
K170158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2020
Device Model NumberN/A
Device Catalogue NumberST020101D
Device Lot NumberREDT4147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2020
Event Location Hospital
Date Manufacturer Received04/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
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