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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, 18 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS ACCUCATH, 18 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number AC0182250
Device Problems Bent (1059); Hole In Material (1293); Retraction Problem (1536)
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 following were reviewed as part of this investigation: patient severity, trend 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 bent needle and failure of the needle to retract into the device housing; however, the root cause was not identified. The product returned for evaluation was one 18ga x 2. 25¿ accucath peripheral iv catheter assembly. The sample was received assembled with the catheter overlaying the needle shaft. The needle shaft was bent at the exit site from the needle carrier. The guidewire was not mobile within the needle. The safety button was depressed; however, the needle was only partially withdrawn into the housing. Guidewire mobility and safety mechanism functionality were established by straightening the needle shaft. Inspection of the guidewire revealed the distal end to be broken. The break site was primarily granular and exhibited a region of increased luster. Microscopic inspection of the device revealed that the portion of guidewire was trapped between the catheter and the needle shaft. The failure of the needle to retract into the housing was caused by guidewire immobility, which was a result of the bend in the needle shaft. It appeared that catheter manipulation while the guidewire was immobile caused the observed guidewire damage. The cause of the bend in the needle shaft was not identified. Consequently this complaint is confirmed as ¿cause unknown¿ at this time. A lot history review (lhr) of rebx1920 showed one other similar product complaint(s) from this lot number.
 
Event Description
It was reported by nurse at the facility that the needle has a hole in it, it is bent and would not retract back into the body for safety. On 4/18/2018 - returned sample has a broken guidewire.
 
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Brand NameACCUCATH, 18 GX2.25
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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 Key7498703
MDR Text Key107828667
Report Number3006260740-2018-00923
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,user f
Reporter Occupation
Type of Report Initial
Report Date 05/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAC0182250
Device Catalogue NumberAC0182250
Device Lot NumberREBX1920
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received04/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2017
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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