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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER
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BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problems Difficult to Insert (1316); Positioning Problem (3009)
Patient Problems Bruise/Contusion (1754); Pain (1994); Tingling (2171); Numbness (2415)
Event Type  Injury  
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported by the patient that she was admitted to the hospital on (b)(6) with chest pain.On (b)(6) a powerglide device was placed, the patient stated that ¿it was the worst experience i have ever had¿ and it that was painful during insertion.It was reported that bruising appeared within 24 hours after it was removed.It was stated it was inserted in the patient¿s arm for about 6 hours.On (b)(6) 2018 the patient went back to the er at the same hospital because of pain, numbness and tingling in the forearm, ring and pinky fingers, also the patient¿s fingers were reported to be ¿ very cold to touch¿.The patient said her blood was taken and then she was told to come back the next day.It was reported the bruising covered the patient¿s entire under area down to the elbow and still has numbing/tingling in the area of the device and a scar where it was placed.(b)(6) 2018 - the patient reported via email that the clinician did use an ultrasound to locate the vein but did not continue to use it during placement of the powerglide pro.She reports that the condition of her arm currently is that she has a lump in the insertion area with a large hole that she believes will become a permanent scar.She also states there is a tender area near her elbow below the insertion site.
 
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 bruising was confirmed from the photos that were provided for investigation, but the exact cause could not be determined.The first photo shows what appeared to be the purple hub from a powerglide catheter that was inserted in the upper arm.The catheter was attached to a statlock.A dressing was covering both the statlock and the powerglide catheter.An extension set extended from the dressing.A sticker that was labeled powerglide was observed on the dressing.Six other photos showed what appeared to be the same upper arm area, but the catheter, statlock, and dressing were not attached to the patient.Varying degrees of what appears to be bruising were observed in the location where the dressing was attached in the first photo.Potential contributing factors of the reported event include insertion technique.The powerglide pro may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported by the patient that she was admitted to the hospital on (b)(6) with chest pain.On (b)(6) a powerglide device was placed, the patient stated that ¿it was the worst experience i have ever had¿ and it that was painful during insertion.It was reported that bruising appeared within 24 hours after it was removed.It was stated it was inserted in the patient¿s arm for about 6 hours.On (b)(6) 2018 the patient went back to the er at the same hospital because of pain, numbness and tingling in the forearm, ring and pinky fingers, also the patient¿s fingers were reported to be ¿ very cold to touch¿.The patient said her blood was taken and then she was told to come back the next day.It was reported the bruising covered the patient¿s entire under area down to the elbow and still has numbing/tingling in the area of the device and a scar where it was placed.(b)(6) 2018 - the patient reported via email that the clinician did use an ultrasound to locate the vein but did not continue to use it during placement of the powerglide pro.She reports that the condition of her arm currently is that she has a lump in the insertion area with a large hole that she believes will become a permanent scar.She also states there is a tender area near her elbow below the insertion site.
 
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Brand Name
POWERGLIDE MIDLINE CATHETER
Type of Device
MIDLINE 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 Key7631716
MDR Text Key112144611
Report Number3006260740-2018-01490
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other Caregivers
Type of Report Initial,Followup
Report Date 07/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2018
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 06/22/2018
Initial Date FDA Received06/22/2018
Supplement Dates Manufacturer Received07/05/2018
Supplement Dates FDA Received07/18/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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