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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number F118108PT
Device Problems Kinked (1339); Failure to Advance (2524)
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 initial complaint appeared to be a non-reportable occurrence. Once the sample was returned and evaluated it was determined that a reportable event had occurred. 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 guidewire complications was confirmed and the cause appeared to be use-related. The product returned for evaluation was two 18ga x 10cm powerglide pro midline catheter assemblies. Both samples were received with the safety mechanisms engaged and the catheters detached. Blood residues were observed throughout both samples. Both guidewires were disengaged from the advancers. Both guidewires appeared to be intact. Microscopic inspection of the first sample (sample 1) revealed a kink in the guidewire near the weld tip. Inspection of the needle revealed mechanical damage along the proximal edge of the bevel. Microscopic inspection of the second sample (sample 2) revealed superficial scoring marks on the coupler. The usage residues, guidewire kink and marks on the coupler were consistent with the guidewire being advanced against resistance during attempted use. Such resistance can occur if guidewire advancement into tissue is attempted and can result in guidewire damage and detachment from the advancer. A lot history review (lhr) of reby2533 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (reby2533) have been reported from the same facility.
 
Event Description
It was reported that the powerglide needle was inserted in the patient's vein, then the "wire wouldn't allow them to advance, it was like it was locked. " it happened twice. On 5/2/2018 - returned samples have blood residue, indicating use on a patient. Both samples have guidewires that were dislodged from the coupler and one guidewire was found to be kinked at the tip. This report address the second device (sample 2).
 
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Brand NameFULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER
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 Key7541044
MDR Text Key109390999
Report Number3006260740-2018-01085
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162377
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 05/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF118108PT
Device Catalogue NumberF118108PT
Device Lot NumberREBY2533
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2017
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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