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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PFLEX, 20G 10CM BASIC KIT (POWERGLIDE PRO) INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS PFLEX, 20G 10CM BASIC KIT (POWERGLIDE PRO) INTRAVASCULAR CATHETER Back to Search Results
Catalog Number F120100
Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2017
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 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 that the guidewire was not sticking out of the needle/safety mechanism was confirmed, but the root cause is unknown. One powerglide flex catheter and needle housing were returned for investigation. Evidence of use was observed on the returned sample. The catheter had been removed from the needle, the guidewire push-off button was fully advanced, the needle was slightly bent, and blood residue was observed on the sample. The safety mechanism had been activated and locked in place over the needle tip. The guidewire was observed within the housing, but was not attached to the coupler. What caused the guidewire to detach from the coupler is unknown, but this can occur if the guidewire push-off button was advanced while the guidewire was constrained in the needle and tissue. Without the wire attached to the coupler, the wire could not be advanced through the needle. The guidewire was complete and intact. After reassembling the guidewire to the coupler, a functional test revealed that the guidewire could be moved in and out of the needle with the push-off button. Due to the condition of the returned product, the guidewire may have detached from the coupler during use. A lot history review (lhr) of rebq0429 showed no other similar product complaint(s) from this lot number.
 
Event Description
Per sales rep, the facility reported that the picc rn placed a 20g powerglide pro and when removing the housing after placement, noticed that the guidewire was not sticking out beyond the safety mechanism. It was stated that the rn was unsure if guidewire was present before procedure and unsure if guidewire was left in patient. The facility is still looking into the matter.
 
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 initial complaint appeared to be a reportable occurrence. Once the sample was returned and evaluated it was determined that a reportable event had not occurred per 21 crf 803. 19.
 
Event Description
Per sales rep, the facility reported that the picc rn placed a 20g powerglide pro and when removing the housing after placement noticed that the guidewire was not sticking out beyond the safety mechanism. It was stated that the rn was unsure if guidewire was present before procedure and unsure if guidewire was left in patient. The facility is still looking into the matter. Sample evaluation shows the guidewire is intact and contained within the housing. The guidewire was out of the coupler so it could not be advanced into the vessel.
 
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Brand NamePFLEX, 20G 10CM BASIC KIT (POWERGLIDE PRO)
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
teresa johnson
605 n. 5600 w.
salt lake city, UT 84116
8015225435
MDR Report Key6575080
MDR Text Key75619170
Report Number3006260740-2017-00626
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,Followup
Report Date 05/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberF120100
Device Lot NumberREBQ0429
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
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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