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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER FULL KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER FULL KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Kinked (1339)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebt2062 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that during catheter insertion the catheter kinked while it was being deployed.The picc nurse verified that the needle was in the center of the vessel via ultrasound.It was stated the guide wire was completely deployed, but the catheter only made it part of the way before it kinked.No harm to the patient was reported.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a kink in the powerglide catheter was inconclusive due to the condition of the sample and since the reported damage could not be detected.One 18g x 10cm powerglide was returned for investigation.The catheter was received separate from the deployment system.The catheter had been removed from the wings.Blood residue was visible in the lumen.A microscopic examination revealed nothing remarkable.A tactual investigation revealed nothing remarkable.No kinks were identified in the powerglide catheter.A functional test revealed that the lumen was patent to infusion and no leaks were observed.The catheter may have been placed in a tortuous location; however, since the reported kink(s) could not be detected in the returned sample, the complaint was inconclusive.A lot history review (lhr) of rebt2062 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that during catheter insertion the catheter kinked while it was being deployed.The picc nurse verified that the needle was in the center of the vessel via ultrasound.It was stated the guide wire was completely deployed, but the catheter only made it part of the way before it kinked.No harm to the patient was reported.
 
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Brand Name
POWERGLIDE MIDLINE CATHETER FULL KIT
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key7310404
MDR Text Key101698314
Report Number3006260740-2018-00330
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741038112
UDI-Public(01)00801741038112
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133856
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberM118101
Device Lot NumberREBT2062
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2018
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received03/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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