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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-MPKB
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2023
Event Type  malfunction  
Event Description
It was reported the glide-thru peel-away sheath would not peel correctly and a portion broke off.No patient harm was reported.The sheath was removed in its entirety and the catheter was placed.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the glide-thru peel-away sheath would not peel correctly and a portion broke off.No patient harm was reported.The sheath was removed in its entirety and the catheter was placed.The patient's condition is reported as fine.
 
Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of sheath tearing incorrectly was able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding, or component damage".The report that a peel-away did not tear correctly was confirmed through complaint investigation of the customer supplied photo.Visual analysis revealed that the sheath split incorrectly along the extrusion.Based on the customer report, the supplied photo, and consultation with r & d, it was determined that manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
 
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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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17920315
MDR Text Key325706752
Report Number9680794-2023-00771
Device Sequence Number1
Product Code PND
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 Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 09/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCDC-41541-MPKB
Device Lot Number33F23C0191
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2023
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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