MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CLEARVUE SLIM ISP, 8FR; IMPLANTABLE PORT

Model Number 5608062

Device Problems Suction Problem (2170); Defective Component (2292)

Patient Problems Ecchymosis (1818); Hematoma (1884); Pain (1994)

Event Date 12/18/2019

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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 03/2020); (b)(4).

Event Description

It was reported that approximately one day post port device implant, the patient allegedly developed a pocket hematoma.It was further reported that as a result of the hematoma, the physician deemed to removed the port.Prior to removing the port, healthcare providers accessed the port, infused with sterile saline, noticed sluggish flow, and swelling and pain of the port site.The physician then removed the port device and the patient did not experience any new symptoms.A temporary peripheral central venous catheter was inserted for chemotherapy to allow the port site tissue to heal.Additionally, upon removal, the silicone septum was allegedly noted to have a level of air/fluid; however, the port and catheter tubing were intact and no tubing leaks were identified.The patient was reported as stable and was discharged after the remove procedure.

Event Description

It was reported that approximately one day post port device implant, the patient allegedly developed a pocket hematoma.It was further reported that as a result of the hematoma, the physician deemed to removed the port.Prior to removing the port, healthcare providers accessed the port, infused with sterile saline, noticed sluggish flow, and swelling and pain of the port site.The physician then removed the port device and the patient did not experience any new symptoms.A temporary peripheral central venous catheter was inserted for chemotherapy to allow the port site tissue to heal.Additionally, upon removal, the silicone septum was allegedly noted to have a level of air/fluid; however, the port and catheter tubing were intact and no tubing leaks were identified.The patient was reported as stable and was discharged after the remove procedure.

Manufacturer Narrative

H10: manufacturing review: the lot met all release criteria.The device history was reviewed and no deviations/issues were identified associated with this problem in regards to product materials or during packaging, manufacturing or quality control inspection processes.All necessary inspections were performed throughout all the manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot, in regards to the described problem.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the ifu instructs on port implantation and accessing the port to conduct flow studies.Therefore, the product labeling will be considered adequate.Investigation summary: one powerport clearvue with attached catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is inconclusive for slow flow and air/fluid in port septum.The returned sample was found to be freely patent to infusion and aspiration, no leaks were observed under hydraulic, and no anomalies were identified in the returned sample.However, the exact circumstances at the time of the reported event could not be recreated during the sample evaluation.The definitive root cause could not be determined based upon available information.H10:g4 h11: h3, h6 (method, results, conclusion, patient: 2091).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.

• Brand Name: POWERPORT CLEARVUE SLIM ISP, 8FR
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9588902
• MDR Text Key: 175031253
• Report Number: 3006260740-2019-04130
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027369
• UDI-Public: (01)00801741027369
• Combination Product (y/n): N
• PMA/PMN Number: K122899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5608062
• Device Catalogue Number: 5608062
• Device Lot Number: REDP4678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 73