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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROV 4F DL IR 135CM NI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS PROV 4F DL IR 135CM NI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Catalog Number S3274335
Device Problems Detachment Of Device Component (1104); Nonstandard Device (1420); Torn Material (3024)
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 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.(b)(4).
 
Event Description
Per medwatch; reportedly, called to assess picc line because of a report that it has a tear in the lumen.When i looked at picc line the purple hub and cap was only barely attached to the picc lumen.When i turned the purple cap to assess it, the purple line came off in my hand.The picc line was then removed and nurse updated.
 
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 break is confirmed and corrective action has been taken regarding failures of this type.One 4 fr dual lumen power picc provena was returned for evaluation.An initial visual observation showed the purple luer hub was missing and use residue was observed throughout the sample.The pinch clamp on the red lumen was observed to be engaged and the pinch clamp on the purple lumen was observed to be missing.The ink on both extension legs was observed to be worn and faded, and a needleless injection cap was observed to be attached to the red luer hub.A microscopic observation revealed the fracture surface of the extension tubing of the purple lumen was rough and exhibited cracks/fissures and beach marks.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
Per medwatch; reportedly, called to assess picc line because of a report that it has a tear in the lumen.When i looked at picc line the purple hub and cap was only barely attached to the picc lumen.When i turned the purple cap to assess it, the purple line came off in my hand.The pic c line was then removed and nurse updated.
 
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Brand Name
PROV 4F DL IR 135CM NI
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
MDR Report Key7445749
MDR Text Key106144864
Report Number3006260740-2018-00764
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741130045
UDI-Public(01)00801741130045
Combination Product (y/n)N
PMA/PMN Number
K162443
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/01/2018,02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberS3274335
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/01/2018
Event Location Hospital
Date Report to Manufacturer03/23/2018
Date Manufacturer Received02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age74 YR
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