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

Catalog Number 4808570J

Device Problems Loose or Intermittent Connection (1371); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being 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 u.S., but is similar to the power port isp m.R.I., 8fr groshong products that are cleared in the us.The pro code, and 510 k number for the power port isp m.R.I., 8fr groshong products are identified.(expiry date: 11/2021).Device pending return.

Event Description

It was reported that during a procedure, the lock on the sheath and dilator allegedly failed to lock.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this product/lot number combination.The device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one introducer peel-apart sheath and vessel dilator were returned for evaluation.Gross visual and microscopic visual evaluations were performed.Two kinks were noted approximately 6.7 cm and 8.4 cm from the distal end of the trocar hand piece.However after review of the preliminary pictures, the manner in which the device was packaged for return may have contributed to the kink.Therefore, the identified kink is determined to be an incidental.The investigation is unconfirmed for the reported loose or intermittent connection, as the internal thread of the vessel dilator and the external threads of the trocar hand piece connector show no anomalies and were able to connect and unconnect without issue.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: the catalog number identified in section d4 has not been cleared in the us but is similar to the power port isp m.R.I., 8fr groshong products that are cleared in the us.The pro code and 510 k number for the power port isp m.R.I., 8fr groshong products are identified in d2 and g4.H10: d4 (expiry date: 11/2021).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 during a procedure, the lock on the sheath and dilator allegedly failed to lock.There was no reported patient injury.

• Brand Name: POWER PORT ISP M.R.I., 8FR GROSHONG
• 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: 10902032
• MDR Text Key: 218201774
• Report Number: 3006260740-2020-20656
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• PMA/PMN Number: K090512
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4808570J
• Device Lot Number: REEQ0299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other