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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25

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BARD ACCESS SYSTEMS ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25 Back to Search Results
Model Number N/A
Device Problems Hole In Material (1293); Leak/Splash (1354)
Patient Problem Blood Loss (2597)
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 of a leak was confirmed, but the exact cause is unknown.One 20g x 1.25¿ accucath catheter was returned for investigation.The catheter was received without the handle.A functional test revealed a leak approximately 6mm distal to the purple strain relief sleeve.A 0.0017¿ hole pointing in the distal direction from inside the catheter to the external surface of the tubing was observed at the leak site.The size of the hole is larger than the outside diameter (od) of the guidewire and smaller than the od of the needle.It is possible that the catheter was punctured with the needle tip, but the exact mechanism of damage is unknown.The product ifu warns, ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.¿ a lot history review (lhr) of reaw1058 showed no other similar product complaint(s) from this lot number.
 
Event Description
As reported by nurse at the facility, they noticed that there was a hole in the proximal third of the catheter where blood was dripping out before fully threading the catheter in the vein.When he noticed the leaking, he removed the catheter from the patient and placed another iv.The patient was not harmed.
 
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Brand Name
ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25
Type of Device
INTRAVASCULAR 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 Key6584610
MDR Text Key75927178
Report Number3006260740-2017-00668
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741110917
UDI-Public(01)00801741110917(17)171228(10)REAW1058
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/28/2017
Device Model NumberN/A
Device Catalogue NumberAC0201250
Device Lot NumberREAW1058
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2017
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 05/11/2017
Initial Date FDA Received05/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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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