MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0602680

Device Problems Fracture (1260); Material Separation (1562); Dent in Material (2526); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/04/2021

Event Type  Injury  

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.However, a video were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2023).

Event Description

It was reported that eleven months post port placement, the catheter allegedly had a break and the distal end of the catheter was missing.It was further reported that the part was dislodged into the right side of the heart as confirmed by fluoroscopy.Reportedly, that the distal catheter segment was removed from the patient.The patient current status was unknown.

Event Description

It was reported that eleven months post port placement, the catheter allegedly had a break and the distal end of the catheter was missing.It was further reported that the part was dislodged into the right side of the heart as confirmed by fluoroscopy.Reportedly, that the distal catheter segment was removed from the patient.The patient current status was unknown.

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 bardport implantable port attached to a catheter was returned for evaluation.Gross visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported catheter fracture, material separation and identified dent in material issues as a complete circumferential break was noted to the catheter approximately 3.7cm from the distal end of the cath-lock that was elliptical in shape.The edges of the complete circumferential break were jagged in one region and rounded in the other region and the surface was smooth in one region and granular in the other region.Further, the investigation is also confirmed for the reported catheter migration issue as a segment was noted to be free floating in the region of right heart in the provided video of live fluoroscopy.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 (expiry date: 01/2023).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.

• Brand Name: M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13116669
• MDR Text Key: 282961277
• Report Number: 3006260740-2021-05476
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025679
• UDI-Public: (01)00801741025679
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K873213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0602680
• Device Catalogue Number: 0602680
• Device Lot Number: RECP0253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/10/2022
• 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