• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 Back to Search Results
Model Number N/A
Device Problems Detachment Of Device Component (1104); Fracture (1260); Leak/Splash (1354)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/22/2017
Event Type  Injury  
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 detached iv catheter is confirmed and was determined to be supplier related. One 20 g accucath iv was returned for evaluation. An initial visual observation showed the iv catheter was detached from the luer connector hub, and a large amount of blood residue was observed on both segments of the sample. A microscopic observation revealed the proximal end of the iv catheter was mostly straight and had radial striations on the majority of its surface. A section of the proximal end¿s surface was observed to be uneven, irregular, and plastically deformed. Plastic deformation was also observed in the catheter just distal to the proximal end; within this region, the surface of the catheter was observed to be more glossy and granular in texture. A slight kink was observed in the catheter approximately one centimeter distal to the proximal end of the catheter. Blood residue was observed in the luer connector hub; however no segment of the iv catheter could be seen within the luer connector hub. The sample was dissected in order to observe the inner lumen of the luer connector and strain relief. A ridge was observed just distal to the proximal opening of the strain relief. This ridge is evidence that the catheter was most-likely malposition during molding of the luer connector and strain relief. The sample was sent to the manufacturing facility for evaluation and it was confirmed that the cause of the catheter breakage it was due to bad positioning in the molding and failure in the stress test. The cause of this complaint is supplier related. The supplier was notified of this event; however, the component is no longer purchased from the supplier. The subject component was purchased from the supplier prior moving the manufacturing process for that component to a bard manufacturing facility. A lot history review (lhr) of rebr0440 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by the facility that the accucath was inserted after one attempt by staff rn with guidance from clinical specialist from bard. It was stated that five hours post insertion the catheter was leaking. When the dressing was removed it was found that the stat lock was intact but catheter had fractured at the hub and the cannula remained inside patients vein. The patient required surgical intervention to remove the cannula, no other adverse outcome.
 
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 rebr0440 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by the facility that the accucath was inserted after one attempt by staff rn with guidance from clinical specialist from bard. It was stated that five hours post insertion the catheter was leaking. When the dressing was removed it was found that the stat lock was intact but catheter had fractured at the hub and the cannula remained inside patient's vein. Catheter was removed with no harm to the patient reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key6644625
MDR Text Key192857160
Report Number3006260740-2017-00787
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 09/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2018
Device Model NumberN/A
Device Catalogue NumberAC0202250
Device Lot NumberREBR0440
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received06/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2017
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: 06/15/2017 Patient Sequence Number: 1
-
-