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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PER-Q-CATH PLUS PICC WITH STIFFENING STYLET WIRE 5F (DUAL-LUMEN)(65CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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PER-Q-CATH PLUS PICC WITH STIFFENING STYLET WIRE 5F (DUAL-LUMEN)(65CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of reav0985 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reav0985) have been reported from the same facility in (b)(6).
 
Event or Problem Description
It was reported that the introducer presented break with only one use.No other information provided.
 
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Brand Name
PER-Q-CATH PLUS PICC WITH STIFFENING STYLET WIRE 5F (DUAL-LUMEN)(65CM)
Common Device Name
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
MDR Report Key8689168
Report Number3006260740-2019-01613
Device Sequence Number16616711
Product Code LJS
UDI-Device Identifier00801741074981
UDI-Public(01)00801741074981
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K954104
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 06/11/2019
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
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue Number4235105
Device Lot NumberREAV0985
Was Device Available for Evaluation? No
Event Location Other
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/21/2019
Initial Report FDA Received Date06/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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