Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN); DRESSING, WOUND, DRUG
  • 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 SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN); DRESSING, WOUND, DRUG Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Skin Irritation (2076)
Event Date 07/27/2020
Event Type  Injury  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported the patient had blister rash with yellow discharge around picc dressing sight.Placement procedure: sight cleansed per protocol with chloraprep, allowed to dry, then used skin prep, placed statlock, gaurdiva patch and transparent dressing over picc sight.Patient guided to take benadryl for extreme itch and to call for prn dressing change for damp dressing due to yellow discharge from blisters.Changes made to treatment.Stopped using chloroprep, only used alcohol swabs, changed transparent dressing to iv3000.
 
Event Description
It was reported the patient had blister rash with yellow discharge around picc dressing sight.Placement procedure: sight cleansed per protocol with chloraprep, allowed to dry, then used skin prep, placed statlock, gaurdiva patch and transparent dressing over picc sight.Patient guided to take benadryl for extreme itch and to call for prn dressing change for damp dressing due to yellow discharge from blisters.Changes made to treatment.Stopped using chloroprep, only used alcohol swabs, changed transparent dressing to iv3000.
 
Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a skin irritation and yellow discharge around the dressing was inconclusive due to poor sample condition.One photo sample of a chloraprep sponge stick was provided for evaluation.It could not be clearly determined if the device has been used.The component lot number was present with lot: 0028882 and expiration date: 01/23; however, the kit product information was not provided.The skin condition of the patient experiencing the reported event was not shown.Based on the description of the reported event, possible contributing factors include patient sensitivity, patient condition, and factors unrelated to components in the picc kit.Since the reported event could not be confirmed from the image provided, the complaint is inconclusive at this time.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN)
Type of Device
DRESSING, WOUND, DRUG
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10490952
MDR Text Key205726095
Report Number3006260740-2020-03126
Device Sequence Number1
Product Code ITX
UDI-Device Identifier00801741037375
UDI-Public(01)00801741037375
Combination Product (y/n)N
PMA/PMN Number
K042445
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberPICK0116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2020
Event Location Hospital
Initial Date Manufacturer Received 08/11/2020
Initial Date FDA Received09/03/2020
Supplement Dates Manufacturer Received09/30/2020
Supplement Dates FDA Received10/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient Weight73
-
-