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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25

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BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 Back to Search Results
Model Number AC0202250
Device Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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 puncture in the accucath catheter was confirmed, and the damage appeared to be use related. One 20g x 2. 25¿ accucath catheter was returned for investigation. Evidence of use was observed on the returned sample. The catheter was received separate from the deployment system. The safety mechanism had been engaged and the needle was fully retracted within the handle. Blood residue was observed within the handle. The guidewire was kinked approximately 1. 6cm from the distal tip. Both the valve and the flow actuator were received over the guidewire. No valve and flow actuator were located within the pink accucath hub. The dimensions of the valve and flow actuator were within specification. A functional test revealed a spraying leak 3. 4cm from the distal tip of the catheter. A microscopic examination of the leak site revealed a symmetrical hole. The inner lumen to external catheter surface trajectory was from the proximal to distal end of the catheter. The characteristics of the hole are consistent with a needle tip puncture. The product ifu states, ¿once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle. If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter. ¿ the complications and manipulation of the device during use appeared to have both damaged the catheter and guidewire and caused the valve and flow actuator to separate from the needle hub. Due to the evidence of use and since the components were within specification, it appears that the device was damaged during use.
 
Event Description
Facility reported to the sales rep that there was a puncture in the catheter of the accucath. No harm to the patient. No other information was provided.
 
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 evaluate. Results are expected soon. A lot history review (lhr) of rebu1351 showed no other similar product complaint(s) from this lot number.
 
Event Description
Facility reported to the sales rep that there was a puncture in the catheter of the accucath. No harm to the patient. No other information was provided.
 
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Brand NameACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
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
shauna nielson
605 n. 5600 w.
salt lake city, UT 84116
8015225536
MDR Report Key6895210
MDR Text Key194205684
Report Number3006260740-2017-01708
Device Sequence Number1
Product Code FOZ
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
Type of Report Initial,Followup
Report Date 11/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAC0202250
Device Catalogue NumberAC0202250
Device Lot NumberREBU1351
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/18/2017
Was Device Evaluated by Manufacturer? Yes
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

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