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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC KIT: 1-L 4.5 FR X 55 CM VPS CATHETER, INTRODUCER

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ARROW INTERNATIONAL INC. ARROW PICC KIT: 1-L 4.5 FR X 55 CM VPS CATHETER, INTRODUCER Back to Search Results
Catalog Number ASK-45541-UMM1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anaphylactic Shock (1703); Nausea (1970); Dizziness (2194)
Event Date 12/07/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: during the procedure for insertion of a picc the patient was oriented and alert. When the nurse was putting on the statlock, the patient claimed to be dizzy, hot, and wanted to vomit. The patient's eyes rolled back and became unresponsive. Patient developed a full body rash. Rapid response was called. Chest x-ray taken, and patient briefly came to but couldn't talk due to a swollen tongue. Medications were given through the picc and then the picc was pulled out of patient. The patient responded well to the medications and became conscious and responsive. Patient had no documented allergy to chlorhexidine. After 24 hours a non- protected picc was inserted and then the patient was discharged.
 
Manufacturer Narrative
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis and it could not be confirmed the patient had any contraindications. A device history record review was performed and no relevant findings were identified. Without the device to evaluate, 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: during the procedure for insertion of a picc the patient was oriented and alert. When the nurse was putting on the statlock, the patient claimed to be dizzy, hot, and wanted to vomit. The patient's eyes rolled back and became unresponsive. Patient developed a full body rash rapid response was called. Chest x-ray taken, and patient briefly came to but couldn't talk due to a swollen tongue. Medications were given through the picc and then the picc was pulled out of patient. The patient responded well to the medications and became conscious and responsive. Patient had no documented allergy to chlorhexidine. After 24 hours a non- protected picc was inserted and then the patient was discharged.
 
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Brand NameARROW PICC KIT: 1-L 4.5 FR X 55 CM VPS
Type of DeviceCATHETER, INTRODUCER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8170855
MDR Text Key130542883
Report Number1036844-2018-00318
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 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2019
Device Catalogue NumberASK-45541-UMM1
Device Lot Number23F18J0341
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/17/2018 Patient Sequence Number: 1
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