MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 9808560

Device Problem Fluid/Blood Leak (1250)

Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the powerport isp m.R.I.Implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, kit, 6f products are identified.

Event Description

It was reported that some time post port placement, the patient allegedly experienced skin inflammation and the subcutaneous leakage was found around the septum.It was further reported that the tip of the catheter was cut for cultivation.The health injury to the patient was unknown.

Event Description

It was reported that some time post port placement, the patient allegedly experienced skin inflammation and the subcutaneous leakage was found around the septum.It was further reported that the tip of the catheter was cut for cultivation.The health injury to the patient was unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the powerport isp m.R.I.Implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, kit, 6f products are identified in d2 and g4.H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one powerport mri isp attached to a catheter was returned for evaluation.Gross visual, microscopic visual and functional testing were performed.A circumferential break was noted approximately 21.1 cm from the distal end of the cath-lock.However, the edge of the complete circumferential break appeared smooth, and the surface appeared finely granular.The investigation is unconfirmed for the reported fluid leak issue, as the port body was patent to infusion and aspiration without issue.A definitive root cause could not be determined based upon the 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.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 ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F
• 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: 11600946
• MDR Text Key: 243324468
• Report Number: 3006260740-2021-01065
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9808560
• Device Catalogue Number: 1806050J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other