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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIRST PICC; PICC LINE
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FIRST PICC; PICC LINE Back to Search Results
Lot Number 11177676
Device Problems Break (1069); Component Falling (1105)
Patient Problem No Information (3190)
Event Date 11/12/2017
Event Type  malfunction  
Event Description
Rn entered room to access patient afternoon feeding.Upon opening isolette cover, it was noted that the picc line has broken in half and was lying in two pieces.The point of breakage was where the catheter meets the argon disc.Tubing leading from the breakage to the iv pole was lying in the bed on the infant's chest.The other half of the tubing from the point of breakage to the point of insertion was secure under the occlusive picc dressing.This catheter was held in place with extra pressure by rn while picc nurse was called to bedside to assess situation.Cnp notified.Picc removed by rn and catheter intact and fully removed from under picc dressing.Pressure applied to site and new picc placed in lower extremity.The area of the catheter where breakage occurred was saved and given to rn.
 
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Type of Device
PICC LINE
Manufacturer (Section D)
FIRST PICC
4202 texana
baytown TX 77520
MDR Report Key7178679
MDR Text Key96869857
Report Number7178679
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot Number11177676
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/27/2017
Event Location Hospital
Date Report to Manufacturer12/27/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NOT APPLICABLE.
Patient Weight2
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