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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI PICC KIT: 2-L 5.5 FR X 50 CM CATHETER,INTRAVASCULAR,THERAPE

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ARROW INTERNATIONAL INC. ARROW PI PICC KIT: 2-L 5.5 FR X 50 CM CATHETER,INTRAVASCULAR,THERAPE Back to Search Results
Catalog Number ASK-45052-TG
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/18/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
On (b)(6) 2020, a 5. 5 french double lumen picc line (cut to 38 cm length) was inserted on a (b)(6) year-old being treated with zosyn, tid, as an outpatient. The insertion was uneventful, easy to advance and had a great blood return to both ports. The patient arrived for an outpatient ct scan yesterday. The radiology team used the picc for iv contrast as is the standard for these pressure rated lines. Immediately on administration of contrast, the patient felt like his upper arm felt tight. Contrast administration was stopped. Pcxr obtained. The anesthesiologist examined the patient, reviewed the chest x-ray and was able to easily remove the line intact. There is an obvious visible fracture at the 5 cm mark.
 
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Brand NameARROW PI PICC KIT: 2-L 5.5 FR X 50 CM
Type of DeviceCATHETER,INTRAVASCULAR,THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key10453773
MDR Text Key206866836
Report Number1036844-2020-00234
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Catalogue NumberASK-45052-TG
Device Lot Number23F19H0218
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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