MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG PORT SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603870C

Device Problems Disconnection (1171); Migration (4003)

Patient Problems Chest Pain (1776); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2025).H11: section a through f ¿ the information provided 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 : device pending return.

Event Description

It was reported that two months and twenty-eight days post a port placement via the right internal jugular vein, the patient allegedly experienced chest pain.It was further reported that upon a chest x-ray examination, the catheter was allegedly found to be detached from the port body and reached the pulmonary artery.Reportedly, the port was removed.The patient was reported to be stable.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f 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 bardport mri hard-base implantable port, one cath-lock, and one groshong catheter in two segments was received for evaluation.Visual, microscopic, tactile, dimensional and functional evaluations were performed.The catheter was noted to be detached from the port body and was returned.The edges of the complete circumferential break on the proximal end of the distal catheter segment were noted to be jagged.The surface was noted to be granular throughout.The distal catheter segment was patent to both infusion and aspiration.No leaks were observed throughout both tests.Therefore, the investigation is inconclusive for the reported disconnection and migration issues as the exact circumstances at the time of the reported event was unknown.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 10/2025), g3.H11: section a through f ¿ the information provided 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 two months and twenty-eight days post a port placement via the right internal jugular vein, the patient allegedly experienced chest pain.It was further reported that upon a chest x-ray examination, the catheter was allegedly found to be detached from the port body and reached the pulmonary artery.Reportedly, the port was removed.The patient was reported to be stable.

• Brand Name: GROSHONG PORT SINGLE LUMEN
• 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: 18524298
• MDR Text Key: 332974596
• Report Number: 3006260740-2023-06144
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133948
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0603870C
• Device Lot Number: REGY2386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2023
• 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
• Patient Outcome(s): Required Intervention