MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. -9617592 POWERPICC SV CATHETER 3F FULL TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recv0964 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (recv0964) have been reported from the same facility.
Event or Problem Description
It was reported that picc line unable to be removed at the bedside, picc placed in the right basilic vein, resistance met after 15-20cms removed, bedside team attempted warm compresses, relaxation (walking, normal activities, etc), cxr confirmed tip in axila and no knots or loops in line, pt referred to ir, no harm to patient, line remained patent during entire dwell time, no cath flo, on ancef, no additional line needed.Line successfully removed in ir with a wire inserted in the single lumen.Pt was exposed to fluro during ir removal.Dr.In special procedures removed line without complication or sedation, patient and parents expressed anxiety during timeframe.No other information was provided.

• Brand Name: POWERPICC SV CATHETER 3F FULL TRAY (SINGLE-LUMEN)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• MDR Report Key: 8378078
• Report Number: 3006260740-2019-00400
• Device Sequence Number: 14217118
• Product Code: LJS
• UDI-Device Identifier: 00801741027529
• UDI-Public: (01)00801741027529
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3173108
• Device Lot Number: RECV0964
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR