MAUDE Adverse Event Report: STATLOCK IV PLUS TRAPEZOIDAL PAD, CLAMSHELL RETAINER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	IV0225
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received by the manufacturer for evaluation.A lot history review (lhr) of jubyf211 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported, an alleged leak at the level of "perfusion" near the catheter.

• Brand Name: STATLOCK IV PLUS TRAPEZOIDAL PAD, CLAMSHELL RETAINER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 8214530
• Report Number: 3006260740-2018-03791
• Device Sequence Number: 228999
• Product Code: FPA
• UDI-Device Identifier: 00801741081712
• UDI-Public: (01)00801741081712
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K980994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 01/03/2019

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 Catalogue Number: IV0225
• Device Lot Number: JUBYF211
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1