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 Problem Loose or Intermittent Connection (1371)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported that during a port placement procedure, the catheter was allegedly loosen than usual when it was attempted to be connected to the port stem.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the power port isp m.R.I., 8fr groshong that are cleared in the us.The pro code and 510 k number for the power port isp m.R.I., 8fr groshong are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiration date: 04/2023.

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 that are cleared in the us.The pro code and 510 k number for the power port isp m.R.I., 8fr groshong are identified in d2 and g4.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport mri implantable port attached to a groshong catheter was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.No cath-lock was returned.During evaluation, the attached groshong catheter was offloaded from the implantable port without issue.No abnormality was noted to both the port stem and the inner diameter of the catheter.The catheter was loaded back to the port stem without issue.However, the investigation is inconclusive for the reported loose or intermittent connection issue, 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.Furthermore, a complete circumferential break was noted on the distal end of the attached catheter.However, striations were noted throughout the surface.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: d4 (expiration date: 04/2023).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 during a port placement procedure, the catheter was allegedly loosen than usual when it was attempted to be connected to the port stem.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
• 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: 15622092
• MDR Text Key: 306908379
• Report Number: 3006260740-2022-04029
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

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: REFZ3156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 01/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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