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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER
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ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER Back to Search Results
Catalog Number CDC-41541-MPKC
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2023
Event Type  malfunction  
Event Description
It was reported that: arm of the peel-away sheath broke off.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4), complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user "withdraw peel-away sheath over catheter until sheath hub and connected portion of sheath is free from venipuncture site.Grasp tabs of peel-away sheath and pull away from the catheter, while withdrawing from vessel until sheath splits down its entire length.Precaution: avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis".A review of dhr revealed findings for which it was not possible to assess the relevance 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: arm of the peel-away sheath broke off.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
 
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Brand Name
ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM
Type of Device
MIDLINE CATHETER
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 Key18254739
MDR Text Key329563141
Report Number9680794-2023-00937
Device Sequence Number1
Product Code PND
UDI-Device Identifier10801902205435
UDI-Public10801902205435
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCDC-41541-MPKC
Device Lot Number33F23C0576
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/05/2023
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
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