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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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TELEFLEX INCORPORATED ARROW; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number IPN037247
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2022
Event Type  malfunction  
Event Description
Patient with a documented chg (chlorhexidine) allergy had chg cvad (central venous access device) inserted.Patient has no local site reaction noted by this author.Product packaging does not easily identify chg in product.Picture submitted to the fda for labeling concerns.The picture illustrates the current packaging.The highlighted area is not currently highlighted but is on this to illustrate the area we are referencing.The red sticker is what the manufacturer has offered to put on the packaging.Manufacturer response for central line kit, pressure injectable arrowg+ard blue plus three-lumen cvc kit (per site reporter).The manufacturer was notified.They have offered to place a sticker on the kit (as seen in the attached photo).Our institution feels this is a risk to patients.
 
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Brand Name
ARROW
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill blvd
morrisville NC 27560
MDR Report Key15698265
MDR Text Key302679425
Report Number15698265
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberIPN037247
Device Catalogue NumberASK-45703-PYNH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/18/2022
Event Location Hospital
Date Report to Manufacturer10/31/2022
Type of Device Usage Unknown
Patient Sequence Number1
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