MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT VUE, ISP, MR, 6F, INTERMEDIATE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1606062

Device Problems Material Erosion (1214); Fluid/Blood Leak (1250); Suction Problem (2170); Material Protrusion/Extrusion (2979)

Patient Problems Extravasation (1842); Pain (1994); Convulsion/Seizure (4406); Swelling/ Edema (4577)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 11/2021).

Event Description

It was reported that post port placement, the device allegedly failed to aspirate blood and had a fluid leak.It was further reported that the patient experienced seizure and neck swelling.The patient's current status was unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one powerport clearvue isp attached to a catheter was returned for evaluation and two photos were provided for review.Visual, microscopic visual, tactile and functional evaluation were performed on the returned device.During functional evaluation, the port body was patent to infusion and aspiration without issue.Hydrostatic pressure was applied by clamping the distal end of the catheter segment while infusing to observe for any anomalies; no such anomalies were noted.The port septum did not appear to bulge when infused.So the investigation is unconfirmed for the reported material protrusion issue.Further, the investigation is confirmed for the identified material erosion issue as the catheter appeared worn between the cath-lock and the 5cm depth mark.However, the investigation is inconclusive for the reported fluid leak and suction problem as the exact circumstances at the time of the reported event are unknown.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed as it is unknown whether the device has caused the patient conditions in the provided photos.The definitive root cause could not be determined based upon available information.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: b2, b5, d4 (expiry date: 11/2021), g3, h6 (patient, device).H11:section a through f - the information provided by bd represents all of 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 Description

It was reported that post port placement, the device allegedly failed to aspirate blood and had a fluid leak.It was further reported that the patient experienced seizure, neck swelling, facial swelling, extravasation and pain.The patient's current status was unknown.

• Brand Name: POWERPORT VUE, ISP, MR, 6F, INTERMEDIATE
• Type of Device: 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: 11929327
• MDR Text Key: 254004525
• Report Number: 3006260740-2021-02128
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026416
• UDI-Public: (01)00801741026416
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1606062
• Device Catalogue Number: 1606062
• Device Lot Number: REET2752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Date Manufacturer Received: 09/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR