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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8" (50 CM); CATHETER, INTRAVASCULAR, THER
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ARROW INTERNATIONAL LLC ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8" (50 CM); CATHETER, INTRAVASCULAR, THER Back to Search Results
Catalog Number PR-05052-HP
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2023
Event Type  malfunction  
Event Description
It was reported that: a rupture of the hose in the proximal lumen of the pic catheter was found.It was reported that it has not been subjected to overpressure or mechanical impact.The issue was identified during use on patient but there was no patient harm or consequence.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "use only lumen(s) labelled "pressure injectable" for pressure injection to reduce risk of catheter failure and/or patient complications.Refer to the arrow pressure injection information label for pressure injection information." a finding in regard to extension line juncture hub separation in use was identified upon device history record review for which further investigations were initiated, but it could not be determined if this is relevant to this reported customer issue without the device sample to evaluate.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
It was reported that: a rupture of the hose in the proximal lumen of the pic catheter was found.It was reported that it has not been subjected to overpressure or mechanical impact.The issue was identified during use on patient but there was no patient harm or consequence.
 
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Brand Name
ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8" (50 CM)
Type of Device
CATHETER, INTRAVASCULAR, THER
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX   31200
Manufacturer Contact
kevin don bosco
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18048223
MDR Text Key327079501
Report Number9680794-2023-00812
Device Sequence Number1
Product Code LJS
UDI-Device Identifier10801902095388
UDI-Public10801902095388
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K042126
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberPR-05052-HP
Device Lot Number14F22M0050
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED
Patient SexMale
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