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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 20G 10CM BASIC; INTRAVASCULAR CATHETER
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BARD ACCESS SYSTEMS PG PRO 20G 10CM BASIC; INTRAVASCULAR CATHETER Back to Search Results
Model Number F120100
Device Problems Material Fragmentation (1261); Physical Resistance (2578)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/15/2017
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 rebt0970 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by the facility that while the nurse was placing the device the wire was deployed successfully and as the nurse was pulling the catheter back he met resistance.It was noted that the catheter broke subcutaneously at the 2cm mark.Ultrasound was done and the catheter was not visible.The physician made the decision to leave the catheter at this point.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 damaged powerglide catheter was confirmed and the damage appeared to be use related.Two 20g x 10cm powerglide flex catheters were returned for investigation.The returned samples resembled the items in the photograph that was provided for investigation.The catheters were still attached to the wings.No other part of the deployment system was returned for investigation.One catheter was curved near the distal end of the pink sleeve and extended 10cm from the pink strain relieve oversleeve.The other catheter extended 7.6cm from the pink strain relieve oversleeve, which indicates that the distal 2.4cm segment of catheter was missing.The hub of the damaged catheter had been rotated within the wings.A microscopic examination of the damaged catheter revealed a longitudinal slit in the distal end of the catheter segment.The portion of the cross section around the longitudinal split appeared smooth and glossy.Material had been removed from the inside surface of the catheter at the longitudinal slit.These characteristics are consistent with a needle puncture.The complete separation of the catheter most likely occurred after the catheter was punctured with the needle.The product ifu warns, ¿once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.This may result in damage to the catheter.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ the ifu also states, ¿do not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure.¿ a lot history review (lhr) of rebt0970 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by the facility that while the nurse was placing the device the wire was deployed successfully and as the nurse was pulling the catheter back he met resistance.It was noted that the catheter broke subcutaneously at the 2cm mark.Ultrasound was done and the catheter was not visible.The physician made the decision to leave the catheter at this point.
 
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Brand Name
PG PRO 20G 10CM BASIC
Type of Device
INTRAVASCULAR 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
shauna nielson
605 n. 5600 w.
salt lake city, UT 84116
8015225536
MDR Report Key7087801
MDR Text Key94143779
Report Number3006260740-2017-02186
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741110535
UDI-Public(01)00801741110535
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 company representative,user f
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberF120100
Device Catalogue NumberF120100
Device Lot NumberREBT0970
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2017
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received12/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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