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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS PFLEX 20G 8CM BASIC KIT INTRAVASCULAR CATHETER Back to Search Results
Model Number N/A
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
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 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 break in the guidewire was confirmed, and the damage appears to be related to use of the device. One powerglide pro deployment system was returned for investigation. The catheter had been removed from the needle and was not returned for investigation. The safety mechanism had been locked over the needle tip. Blood residue was observed in the handle. No portion of the guidewire was protruding from the distal tip of the safety mechanism. The safety mechanism was removed from the needle and the distal tip of the needle was microscopically examined. There was a break in the wire that coincided with the tip of the needle. The distal tip of the wire was not returned for investigation. The fractured end of the wire exhibited necking and a granular tip, which is consistent with a tensile break. The inner edge of the needle bevel exhibited deformation, which is indicative of force between the wire and the needle bevel. No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use. A lot history review (lhr) of rebn2178 showed no other similar product complaint(s) from this lot number.
 
Event Description
Per sales rep, the facility reported that during placement of the powerglide the wire broke off and remained in the patients subcutaneous tissue. It was stated that the wire was removed in ir and there was no permanent damage to the patient.
 
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Brand NamePFLEX 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 Key6584611
MDR Text Key75761451
Report Number3006260740-2017-00671
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 05/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2019
Device Model NumberN/A
Device Catalogue NumberF120080
Device Lot NumberREBN2178
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2017
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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