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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI AGBA PICC KIT: 3-L 6 FR X 40 CM W/VPS; INTRODUCER, CATHETER
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ARROW INTERNATIONAL INC. ARROW PI AGBA PICC KIT: 3-L 6 FR X 40 CM W/VPS; INTRODUCER, CATHETER Back to Search Results
Catalog Number CDC-44063-VPS2
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
Customer reported the catheter was leaking at the insertion site.When the picc was removed, a rupture was observed in the medial lumen.A new picc was inserted in the patient.No patient harm reported.It was reported the patient remained on a ventilator in prone position due to active covid infection at the time of this report.
 
Manufacturer Narrative
Qn# (b)(4).The customer returned one 3-lumen picc for evaluation.Visual examination revealed the catheter body was ruptured near the juncture hub.The walls of the ruptured material appeared thinned, which is damage consistent with over-pressurization causing a rupture.The catheter body appeared intentionally cut.The catheter body was ruptured 13 mm from the juncture hub.The total length of the catheter body measured to be 14 2/16" which is not within specifications of 16 13/16" - 17 1/16" per product drawing.This indicates that at least 2 11/16" were not returned.The outer diameter of the catheter body in an undamaged location measured to be 0.079" which is less than the maximum specification of 0.083" per product drawing.Functional inspection was performed to recreate the product's intended use.The ifu provided with this kit states the following: "flush catheter using a 10 ml syringe, or larger, filled with sterile normal saline." the three lumens were initially flushed to ensure no blockages were present.When the medial lumen was flushed, water exited the ruptured portion of the catheter.The distal and proximal lumens functioned as expected.A device history record review was performed with no relevant findings.The ifu provided with this kit cautions the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi), to reduce the risk of intraluminal leakage or catheter rupture." the customer report of a catheter rupture was confirmed by complaint investigation of the returned sample.The catheter body was ruptured adjacent to the juncture hub.A device history record review was performed with no relevant findings.Based on the condition of the sample received and the information available , unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
Customer reported the catheter was leaking at the insertion site.When the picc was removed, a rupture was observed in the medial lumen.A new picc was inserted in the patient.No patient harm reported.It was reported the patient remained on a ventilator in prone position due to active covid infection at the time of this report.
 
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Brand Name
ARROW PI AGBA PICC KIT: 3-L 6 FR X 40 CM W/VPS
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11488534
MDR Text Key242705448
Report Number9680794-2021-00100
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Catalogue NumberCDC-44063-VPS2
Device Lot Number13F20K0202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2021
Date Manufacturer Received04/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED
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