• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Detachment Of Device Component (1104); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/06/2018
Event Type  Injury  
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 following were reviewed as part of this investigation: patient severity, trend 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 powerglide luer detachment was confirmed and the cause appeared to be manufacturing-related. The product returned for evaluation was five photographs depicting an 18ga x 10cm powerglide midline catheter. The first two photographs depicted the luer adapter and over-mold. The catheter appeared to be detached from the over-mold. The remaining three photographs depicted a catheter tube. Blood residue was evident within the photograph. The proximal end of the catheter appeared to be detached from the luer/over-mold. The proximal end of the catheter appeared to be the manufacture end. The catheter depicted in the photographs appeared to have become detached from the over-mold. Such a detachment can occur if the catheter is not fully inserted on the core pin during the molding process. The photographs will be submitted to the manufacturing site for further evaluation. A lot history review (lhr) of recp2382 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the insertion of the midline was successful with no issues. Directly after insertion, the nurse lifted the catheter at the hub to place a statlock and heard a pop. The facility stated that, ¿the pop sound is assumed to be the hub separating from the catheter itself. ¿ the patient had to go to ir to have product removed. They also noted that they put a tourniquet on the patient to "keep catheter from migrating. " no patient injury reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
tesha udy
605 n. 5600 w.
salt lake city, UT 84116
8015225819
MDR Report Key7561269
MDR Text Key109885435
Report Number3006260740-2018-01181
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741038105
UDI-Public(01)00801741038105
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
Type of Report Initial
Report Date 06/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM118100
Device Catalogue NumberM118100
Device Lot NumberRECP2382
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-