MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT VUE M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1808052
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 07/2019).
Event or Problem Description
It was reported that post port device implant and upon removal of the port, the catheter was allegedly found to be cracked.Upon inspection, the device was found to have a leak.It was further reported that the patient allegedly experienced pain and extravasation.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: one powerport clearvue isp was returned for evaluation.Gross, microscopic visual evaluation and functional testing were performed.The investigation is confirmed for the reported cracked catheter, leak, pain and extravasation issue as a longitudinal split was noted from the distal end of the cath-lock.The cath-lock was not seated against the port body.The port body and attached catheter were patent to infusion with a leak noted at the longitudinal split.While infusing blood was noted exiting both the leak and the distal end.Aspiration of water into the syringe was attempted but was unsuccessful; air was aspirated into the syringe.A definitive root cause could not be determined.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 07/2019), g3, h6(method).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that post port device implant and upon removal of the port, the catheter was allegedly found to be cracked.Upon inspection, the device was found to have a leak.It was further reported that the patient allegedly experienced pain and extravasation.The current status of the patient is unknown.

• Brand Name: POWERPORT VUE M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11341879
• Report Number: 3006260740-2021-00383
• Device Sequence Number: 610647
• Product Code: LJT
• UDI-Device Identifier: 00801741027024
• UDI-Public: (01)00801741027024
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 1808052
• Device Catalogue Number: 1808052
• Device Lot Number: RECP1138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 06/07/2021
• 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: Other