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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CG+ PICC/DELTA FG: 2-L 5.5 FR X 50 CM CATHETER INTRODUCER

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ARROW INTERNATIONAL INC. ARROW CG+ PICC/DELTA FG: 2-L 5.5 FR X 50 CM CATHETER INTRODUCER Back to Search Results
Catalog Number CDC-45052-VPS2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Vomiting (2144); No Consequences Or Impact To Patient (2199)
Event Date 03/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The sales force complaint form indicates "no patient injury or consequence". It is noted that the patient had no documented allergies.
 
Event Description
The customer reports: patient required a picc line for tpn. Customer set up to place a 5. 5fr double lumen coated catheter (lot#23f17k0047). The minute it was started to thread the coated catheter the patient began to have symptoms of an allergic reaction which included: nausea and vomiting. I immediately removed the coated catheter and put the dilator back into the sheath. The patient's symptoms resolved as soon as the coated catheter was removed from the patient. A non-coated 4fr double lumen bard catheter was placed and the patient had no further signs of an allergic reaction.
 
Manufacturer Narrative
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed and no relevant findings were identified. 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
The customer reports: patient required a picc line for tpn. Customer set up to place a 5. 5fr double lumen coated catheter (lot#23f17k0047). The minute it was started to thread the coated catheter the patient began to have symptoms of an allergic reaction which included: nausea and vomiting. I immediately removed the coated catheter and put the dilator back into the sheath. The patient's symptoms resolved as soon as the coated catheter was removed from the patient. A non-coated 4fr double lumen bard catheter was placed and the patient had no further signs of an allergic reaction.
 
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Brand NameARROW CG+ PICC/DELTA FG: 2-L 5.5 FR X 50 CM
Type of DeviceCATHETER INTRODUCER
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 Key7357410
MDR Text Key103175198
Report Number1036844-2018-00097
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberCDC-45052-VPS2
Device Lot Number23F17K0047
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/21/2018 Patient Sequence Number: 1
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