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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. -9617592 ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD REYNOSA S.A. DE C.V. -9617592 ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number AC0202250
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
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 damaged catheter was confirmed and the cause appeared to be use-related. The product returned for evaluation was one 20ga x 2. 25¿ accucath catheter. Blood residue was evident within the catheter tube. The sample was received in two segments which shared a complete break approximately 2cm distal of the molded joint. Multiple kinks were apparent along the length of the distal fragment. The break appeared irregular. Elongation and curved shape memory were evident in the vicinity of the break. Microscopic inspection of the break confirmed extensive deformation/elongation. The break surface was partially granular and partially striated. The striated region exhibited a tapered profile. Inspection of the tip of the catheter revealed deformation. The catheter fracture features were consistent with damage that was initiated by contact between the catheter and the needle tip and propagated by tensile (pulling) stress. The abundant kinks and catheter tip damage suggested possible difficulty experienced during catheter insertion/guidewire retraction. The product ifu states ¿warning: do not force or retract the guidewire. ¿ and ¿warning: 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. ¿ a lot history review (lhr) of recn0849 showed no other similar product complaint(s) from this lot number. (b)(4).
 
Event Description
It was reported that patient was undergoing an insertion of a peripheral vascular access device using ultrasound. Accucath was inserted and wire advanced without difficulty in right cephalic vein with good blood return noted. During retraction of wire the wire got "hung up" and the practitioner attempted to pull back on the catheter. The needle tip caught the end of the catheter resulting in a shearing off of the tip of the catheter. The iv catheter tip was surgically removed and patient tolerated procedure without complications noted.
 
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Brand NameACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
tesha udy
605 n. 5600 w.
salt lake city, UT 84116
8015225819
MDR Report Key7651921
MDR Text Key112788581
Report Number3006260740-2018-01563
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/23/2018,06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberAC0202250
Device Catalogue NumberAC0202250
Device Lot NumberRECN0849
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/23/2018
Event Location Hospital
Date Report to Manufacturer06/08/2018
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/29/2018 Patient Sequence Number: 1
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