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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 18G 10CM CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 18G 10CM CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number M118100
Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
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 recn1704 showed one other similar product complaint(s) from this lot number.
 
Event Description
It was reported via sales rep from facility that "mid line was being placed in the cephalic vein, wire would not deploy due to resistance met , wire did not lock into place due to resistance met immediately, wire was pulled back and catheter was repositioned via ultra sound guidance, wire deployed and catheter advanced without resistance, catheter would not flush and was pulled out, distal tip of catheter kinked approximately 1 cm from the end of the catheter. ".
 
Manufacturer Narrative
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. The returned sample exhibited no evidence of the alleged event. The event is unconfirmed per the investigation results. Since no device malfunction occurred and there is no allegation of a serious injury to a patent, user, or other person, this event is deemed not reportable per 21 cfr part 803.
 
Event Description
It was reported via sales rep from facility that "mid line was being placed in the cephalic vein, wire would not deploy due to resistance met , wire did not lock into place due to resistance met immediately, wire was pulled back and catheter was repositioned via ultra sound guidance, wire deployed and catheter advanced without resistance, catheter would not flush and was pulled out, distal tip of catheter kinked approximately 1 cm from the end of the catheter. ".
 
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Brand NamePOWERGLIDE MIDLINE CATHETER, 18G 10CM
Type of DeviceCATHETER,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 Key7811517
MDR Text Key118254114
Report Number3006260740-2018-02213
Device Sequence Number1
Product Code FOZ
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM118100
Device Catalogue NumberM118100
Device Lot NumberRECN1704
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received09/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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