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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 BIOPATCH 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 BIOPATCH AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number F318108PT
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents. Based on a review of this information, the following was concluded: the complaint of safety mechanism failure was confirmed; however, the root cause was not identified. The product returned for evaluation was one 18ga power glide pro midline catheter assembly. Usage residues were observed throughout the sample. The catheter had been advanced and was not returned. The catheter advancement wings were detached from the assembly, and the safety mechanism outer housing was still attached to the wings. The remainder of the safety mechanism was not returned for evaluation. Microscopic inspection of the safety mechanism housing revealed it to appear properly formed. Stress fracturing was observed near one of the securement features. While the safety mechanism was observed to have become detached from the needle shaft, inspection of the returned safety housing was insufficient to identify the cause of that detachment, and the remaining safety mechanism components were not returned for evaluation. Consequently this complaint is confirmed as ¿cause unknown¿ at this time. A lot history review (lhr) of redn3382 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported nurse inserted a power glide in right basilic vein, deployed guidewire and removed power glide handle. At this time i noticed that the needle was not sharp and the guidewire was intact. The green winged catheter advancer was found to have the top half of the ¿sharp¿ housing and the bottom half was still in the handle. The two halves separated and there was no way to ¿sharp¿ the needle. No harm done to the patient. 7/11/2019 - returned sample shows a defective safety mechanism.
 
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Brand NameFULL KIT 18G X 10 CM WITH BIOPATCH 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
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key8854957
MDR Text Key153798261
Report Number3006260740-2019-02285
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF318108PT
Device Catalogue NumberF318108PT
Device Lot NumberREDN3382
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received07/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2019
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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