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

Model Number 9808560

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 12/08/2020

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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that post port device implant, the patient allegedly experienced severe pain during infusion.It was further reported that leakage was noted upon examination.Upon device removal, the catheter was allegedly found to be damaged near the port stem.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review, 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 groshong catheter were returned for evaluation.Visual, microscopic visual and functional evaluations were performed.The investigation is confirmed for catheter fracture, catheter leak, deformation and naturally worn as a circumferential split was noted just distal to the distal end of the cath-lock with the edges of the split being rounded and jagged.Additionally, the port body and attached catheter were patent to infusion with a leak noted at the circumferential split.Aspiration of water into the syringe was attempted but was unsuccessful; air was aspirated into the syringe.The identified break is typical of flexural fatigue, which is due to the repetitive, kinking of the catheter.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: g3 h11: h6(result, conclusion) 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.H3 other text : see h10.

Event Description

It was reported that post port device implant, the patient allegedly experienced severe pain during saline infusion.It was further reported that leakage was noted upon ct examination.Upon device removal, the catheter was allegedly found to be damaged near the port stem.The current status of the patient is unknown.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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: 11099760
• MDR Text Key: 224524901
• Report Number: 3006260740-2020-21137
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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: 9808560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other