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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV 4F DL MAX TLS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS DOT PROV 4F DL MAX TLS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Break (1069); Kinked (1339)
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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of rebu0691 showed no other similar product complaint(s) from this lot number.
 
Event Description
Reported by facility that this picc was placed (b)(6) 2017, removed (b)(6) 2017 because of kinks in catheter and a break at the hub of the purple lumen hub.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a break in the extension leg tubing is confirmed; however the cause is unknown and an internal investigation is currently ongoing to determine the root cause.One 4 fr dual lumen powerpicc provena was returned for evaluation.An initial visual observation showed use residue throughout the sample.A large split was observed in the purple extension leg near the distal end of the luer connector.Both lumens of the sample were flushed and pressurized with a 12 ml syringe of water.The red lumen was found to be patent to infusion and aspiration and no leaks were found when the lumen was pressurized; however, leakage was observed emanating from the split in the tubing of the purple lumen.A microscopic observation revealed several beach marks and cracks on the break surface of the purple lumen, which are suggestive of material fatigue.The tubing material was observed to be attached to the luer connector at irregular points along the tubing¿s circumference, and cracking appeared to have initiated at one or more of these points.The beginning of a split was observed in the tubing of the red lumen and cracks similar to those observed on the purple lumen were observed on the break surface of the beginning of a split in the red lumen.An internal investigation is currently ongoing to determine the root cause of this splitting; reference (b)(4) for further information.A lot history review (lhr) of rebu0691 showed no other similar product complaint(s) from this lot number.
 
Event Description
Reported by facility that this picc was placed (b)(6) 2017, removed (b)(6) 2017 because of kinks in catheter and a break at the hub of the purple lumen hub.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a break in the extension leg tubing is confirmed; however the cause is unknown and an internal investigation is currently ongoing to determine the root cause.One 4 fr dual lumen powerpicc provena was returned for evaluation.An initial visual observation showed use residue throughout the sample.A large split was observed in the purple extension leg near the distal end of the luer connector.Both lumens of the sample were flushed and pressurized with a 12 ml syringe of water.The red lumen was found to be patent to infusion and aspiration and no leaks were found when the lumen was pressurized; however, leakage was observed emanating from the split in the tubing of the purple lumen.A microscopic observation revealed several beach marks and cracks on the break surface of the purple lumen, which are suggestive of material fatigue.The tubing material was observed to be attached to the luer connector at irregular points along the tubing¿s circumference, and cracking appeared to have initiated at one or more of these points.The beginning of a split was observed in the tubing of the red lumen and cracks similar to those observed on the purple lumen were observed on the break surface of the beginning of a split in the red lumen.An internal investigation is currently ongoing to determine the root cause of this splitting; reference (b)(4) for further information.A lot history review (lhr) of rebu0691 showed no other similar product complaint(s) from this lot number.
 
Event Description
Reported by facility that this picc was placed (b)(6) 2017, removed (b)(6) 2017 because of kinks in catheter and a break at the hub of the purple lumen hub.
 
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Brand Name
DOT PROV 4F DL MAX TLS
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
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key6945853
MDR Text Key89713074
Report Number3006260740-2017-01830
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741130441
UDI-Public(01)00801741130441
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 02/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberS9274108D
Device Lot NumberREBU0691
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2017
Is the Reporter a Health Professional? No
Event Location Hospital
Date Manufacturer Received12/28/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2017
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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