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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPICC BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS PPICC BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Catalog Number 3275118J
Device Problems Fluid/Blood Leak (1250); Aspiration Issue (2883)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 device has not been returned, at this time, to the manufacturer for evaluation.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 that when attempting to infuse medical solution via the alleged device, the medicine allegedly leaked from the insertion site, so the device was removed.There was no reported patient injury.Reportedly, the device was implanted via the basilica vein and the event occurred approximately 4 days after the placement.Confirmation of blood backflow and flush of the both lumens were performed without any problem; however, when blood collecting, it was allegedly difficult to aspirate blood.
 
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 leak is unconfirmed as the alleged problem could not be reproduced.One 5 fr dual lumen powerpicc was returned for evaluation.An initial visual observation showed use residue on the returned sample.Both lumens of the catheter were flushed and pressurized.Both lumens were found to be patent to infusion and aspiration and no leaks were observed.As a note, the formation and buildup of fibrin could cause infusate to be directed back toward the insertion site as well as difficulties aspirating.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 that when attempting to infuse medical solution via the alleged device, the medicine allegedly leaked from the insertion site, so the device was removed.There was no reported patient injury.Reportedly, the device was implanted via the basilica vein and the event occurred approximately 4 days after the placement.Confirmation of blood backflow and flush of the both lumens were performed without any problem; however, when blood collecting, it was allegedly difficult to aspirate blood.
 
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Brand Name
PPICC BASIC
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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 Key7467281
MDR Text Key106863475
Report Number3006260740-2018-00822
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741111679
UDI-Public(01)00801741111679
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K051672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3275118J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2018
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received05/04/2018
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
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