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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number N/A
Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/18/2017
Event Type  Injury  
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. One 20ga x 10cm powerglide catheter and deployment system were returned for investigation. The returned sample revealed evidence of use. The catheter was received separate from the deployment system. The catheter wings had been removed from the catheter. The guidewire button had been fully advanced and the safety mechanism was activated over the needle. The guidewire was kinked 1. 3cm from the distal tip of the wire. What appeared to be blood residue was observed within the safety mechanism and catheter. The catheter extended 3. 5cm from the distal tip of the pink strain relief sleeve, which indicates that approximately 6. 5cm of the catheter was missing. The distal end of the catheter was not returned for investigation. A microscopic examination of the catheter revealed a longitudinal slit in the distal end of the catheter segment, which is consistent with a needle puncture. The section of catheter around the longitudinal split exhibited a smooth and glossy surface. It appears that the needle punctured through the side of the catheter. 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. ¿ the observed damage and reported complications appear to be related to use of the device. No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use. A lot history review (lhr) of reaw0125 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported the catheter was placed with ultrasound, but there was no blood drawback after placement. The physician pulled back the catheter completely and noted there was only 4 cm of the catheter left. The rest, 6cm, was still in the patient. The surgeon performed a sonogram with echo and an x-ray, but the rest of catheter was not seen.
 
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 reaw0125 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported the catheter was placed with ultrasound, but there was no blood drawback after placement. The physician pulled back the catheter completely and noted there was only 4 cm of the catheter left. The rest, 6 cm, was still in the patient. The surgeon performed a sonogram with echo and an x-ray, but the rest of catheter was not seen.
 
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Brand NamePOWERGLIDE MIDLINE CATHETER
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 Key6784802
MDR Text Key192870843
Report Number3006260740-2017-01266
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K121073
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number6020100
Device Lot NumberREAW0125
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received12/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/10/2017 Patient Sequence Number: 1
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