MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8808560

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Material Puncture/Hole (1504); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)

Patient Problems Inflammation (1932); Burning Sensation (2146)

Event Date 03/20/2022

Event Type  Injury  

Event Description

It was reported that two years and eleven months post port placement procedure, the port was allegedly had a leak.It was further reported that catheter had two holes in the subcutaneous part.Reportedly, patient experienced burning sensation and inflammation which required treatment with antibiotics.The port system was removed.The current status of the patient is unknown.

Manufacturer Narrative

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.(expiry date: 02/2021).

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one powerport mri isp implantable port attached to a groshong catheter was returned for evaluation.Gross visual, microscopic visual, tactile evaluation and functional testing were performed.The investigation is unconfirmed for the reported catheter hole issue as fracture was identified during return sample evaluation.However, the investigation is confirmed for the reported fluid leak and identified fracture, wear and deformation issues as a two partial circumferential breaks were noted approximately 7.8cm and 8.4cm from the distal end of the cath-lock.Under microscopic observation, the surface of both the partial circumferential breaks were noted to be round and glossy in both region.Further, a split was noted on the catheter approximately 7.2 cm, proximal to the partial circumferential breaks.Upon infusion, leaks were observed from the partial circumferential breaks on the catheter.Furthermore, clinical conditions alleged in the complaint such as burning sensation and inflammation cannot be confirmed.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.The definitive root cause could not be determined based upon 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 (expiry date: 02/2021), g3, h6 (device).H11: g1, h6(method, result, conclusion).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.H3 other text : see h10.

Event Description

It was reported that two years and eleven months post port placement procedure, the port was allegedly had a leak.It was further reported that catheter had two holes in the subcutaneous part.Reportedly, patient experienced burning sensation and inflammation which required treatment with antibiotics.The port system was removed.The current status of the patient is unknown.

• Brand Name: POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL
• 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: 14098513
• MDR Text Key: 289175771
• Report Number: 3006260740-2022-01238
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098994
• UDI-Public: (01)00801741098994
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8808560
• Device Lot Number: REDQ1166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female