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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE. LTD. CAREFLOW CENTRAL VENOUS CATHETER

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MERIT MEDICAL SINGAPORE PTE. LTD. CAREFLOW CENTRAL VENOUS CATHETER Back to Search Results
Catalog Number 681662
Device Problems Break (1069); Fracture (1260)
Patient Problems Obstruction/Occlusion (2422); Patient Problem/Medical Problem (2688)
Event Date 02/08/2018
Event Type  Injury  
Manufacturer Narrative
The suspect device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleged after insertion of the central venous catheter (cvc) it was discovered that it was not possible to draw blood and difficult to inject fluid. Upon inspection the hub was cracked. This was a pediatric patient with ileus in need of total parenteral nutrition (tpn). The patient was an in-patient who was taken back into the operating room later that night for additional anesthesia to place a new cvc. The physician administered the extra anesthesia because of the patient's current condition and age. No patient injury to report.
 
Manufacturer Narrative
The suspect device was returned for evaluation. The device was examined visually. The complaint is confirmed. The root cause could not be confirmed, however, it is likely that the hub was over-tightened during use. A review of the device history record was performed and no exception documents were found. A review of the complaint database was performed and no similar complaints for this lot number were found.
 
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Brand NameCAREFLOW CENTRAL VENOUS CATHETER
Type of DeviceCENTRAL VENOUS CATHETER
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE. LTD.
198 yishun ave. 7
singapore, sg-03 76892 6
SN 768926
Manufacturer (Section G)
MERIT MEDICAL SINGAPORE PTE. LTD.
198 yishun ave. 7
singapore, sg-03 76892 6
SN 768926
Manufacturer Contact
casey hughes, ms, cqe, csqp
1600 merit parkway
south jordan, UT 84095
MDR Report Key7364325
MDR Text Key103268655
Report Number8020616-2018-00004
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K033500
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2022
Device Catalogue Number681662
Device Lot Number705192
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2017
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: 03/22/2018 Patient Sequence Number: 1
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