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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BARD ACCESS SYSTEMS 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
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 redq0535 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the wire was not housed inside the casing, and sprung out during insertion.There have also been some instances some midlines where the clear casing at the bottom was already loose prior to insertion.The wire has been becoming detached from the casing, either prior to insertion, or during insertion.
 
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 initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.
 
Event Description
It was reported that the wire was not housed inside the casing, and sprung out during insertion.There have also been some instances some midlines where the clear casing at the bottom was already loose prior to insertion.The wire has been becoming detached from the casing, either prior to insertion, or during insertion.(b)(6) 2020 - returned product has a fully intact wire without damage or defect.The investigation is unconfirmed.
 
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Brand Name
20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC 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
MDR Report Key10175384
MDR Text Key195784111
Report Number3006260740-2020-02132
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741138614
UDI-Public(01)00801741138614
Combination Product (y/n)N
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number6F120080
Device Lot NumberREDQ0535
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2020
Event Location Hospital
Date Manufacturer Received07/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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