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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 20G 8CM BASIC KIT INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS PG PRO 20G 8CM BASIC KIT INTRAVASCULAR CATHETER Back to Search Results
Model Number N/A
Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528); Physical Resistance (2578)
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 device has not been returned to the manufacturer, at this time, for evaluation. A lot history review (lhr) of rebp1302 showed no other similar product complaint(s) from this lot number. Device not yet returned for evaluation.
 
Event Description
Per sales rep, the facility reported the nurse was placing power glide pro and felt resistance. The rn tried to pull back on device, felt resistance, and saw skin movement around insertion site due to the resistance. It was stated the rn did not want to force the device removal with added pressure so the rn advance the catheter slightly and was successful in removing the device. Once the device was removed from the patient, it was noted that the wire had broken off the device and was inside the catheter. The rn measured the wire against another new device and it was reportedly intact without any part of the wire remaining inside the patient. An x-ray order was placed and a physician was consulted to ensure patient safety.
 
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Brand NamePG PRO 20G 8CM BASIC KIT
Type of DeviceINTRAVASCULAR CATHETER
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 Key6672342
MDR Text Key78589764
Report Number3006260740-2017-00915
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 06/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model NumberN/A
Device Catalogue NumberF120080
Device Lot NumberREBP1302
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2017
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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