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 Complete Blockage (1094); Difficult to Flush (1251); Suction Problem (2170); Defective Component (2292); Failure to Infuse (2340)

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

Event Date 11/18/2020

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 device has been returned to the manufacturer for evaluation.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 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 procode and pma/510k.(expiry date: 11/2021).

Event Description

It was reported that prior to a procedure, the device allegedly unable to infuse.There was no patient contact.

Manufacturer Narrative

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: manufacturing review: a complaint history review was performed.This is the third complaint reported for this lot number and the lot met all release criteria.A device history record review is required.Investigation summary: one safety infusion set was returned for evaluation.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported infusion and aspiration difficulty and identified complete blockage and defective device as the infusion set was unable to be infused and aspirated during functional evaluation and a material consistent with manufacturing adhesive was noted in one of the luers, obstructing the flow.The cause of suction problem, unable to flush and nonstandard device issues was identified to be supplier related, as condition was caused during the bonding process at supplier facility.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: d4 (expiry date: 11/2021), g3, h6 (method).H11: h6 (device, result and 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.

Event Description

It was reported that prior to a procedure, the device allegedly was unable to infuse.There was no patient contact.

• 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: 11018746
• MDR Text Key: 221854859
• Report Number: 3006260740-2020-20936
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• PMA/PMN Number: K081311
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: REEN1421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other