MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 LOW ARTIFACT POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number UNK LOW ARTIFACT POWER PORT

Device Problems Material Discolored (1170); Material Disintegration (1177); Fluid/Blood Leak (1250); Difficult to Flush (1251); Fracture (1260); Material Puncture/Hole (1504); Obstruction of Flow (2423); Noise, Audible (3273)

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

Event Date 01/28/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records 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 sometime post port implant in the upper left chest, the device was allegedly difficult to be assessed, flushed and was noted to be clogged.The device was removed off the patient and upon assessment the material was noted to be disintegrated, discolored and a hole was noted on the back of the port and the septum of the device was also noted to be leaking into the catheter.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records 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 sometime post port implant in the upper left chest, the device was allegedly difficult to be assessed, flushed and was noted to be clogged.The device was removed off the patient and upon assessment the material was noted to be disintegrated, discolored and a hole was noted on the back of the port and the septum of the device was also noted to be leaking into the catheter.There was no reported patient injury.

Event Description

It was reported that sometime post port implant in the upper left chest, the device was allegedly difficult to be assessed, flushed and was noted to be clogged.The device was removed off the patient and upon assessment the material was noted to be disintegrated, discolored and a hole was noted on the back of the port and the septum of the device was also noted to be leaking into the catheter.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one clearvue powerport isp implantable port, one cath-lock and one catheter in six segments were returned for evaluation.Gross visual evaluation was performed.The investigation is inconclusive for the reported difficult to flush, material disintegration, discolored, noise and device clogged issues, as the exact circumstances at the time of the reported event cannot be verified, and the reported event could not be reproduced in the lab.The investigation is confirmed for the reported hole and leak issues, as a fracture was noted to the bottom region of the silicone overmold.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.H10: g3, h6 (method) 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.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one clearvue powerport isp implantable port, one cath-lock and one catheter in six segments were returned for evaluation.Gross visual evaluation was performed.The investigation is inconclusive for the reported difficult to flush, noise and fluid leak issues, as the exact circumstances at the time of the reported event cannot be verified, and the reported event could not be reproduced in the lab.The investigation is unconfirmed for the reported material puncture/hole, material disintegration and discolored.The investigation is confirmed for the reported obstruction of flow and the identified fracture issues, as a fracture was noted to the bottom region of the silicone overmold and the port reservoir was noted to have residue within.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.

Event Description

It was reported that sometime post port implant in the upper left chest, the device was allegedly difficult to be assessed, flushed and was noted to be clogged.The device was removed off the patient and upon assessment the material was noted to be disintegrated, discolored and a hole was noted on the back of the port and the septum of the device was also noted to be leaking into the catheter.There was no reported patient injury.

• Brand Name: LOW ARTIFACT POWER PORT
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13596692
• MDR Text Key: 286118960
• Report Number: 3006260740-2022-00458
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LOW ARTIFACT POWER PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1