MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0602833

Device Problems Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)

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

Event Date 10/13/2022

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 return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.

Event Description

It was reported that two years and three months post port placement procedure, the catheter allegedly broke.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 bardport implantable port attached to a catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.The investigation is confirmed for the reported catheter fracture, and the identified material separation, wear and deformation issues, as a complete circumferential break was noted on the distal end of the catheter and the surface was noted to be granular in one region and round in the other region and kinks were noted throughout the catheter.Furthermore, a longitudinal split was noted at the border of both regions.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: g3, h6 (device).H11: 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 three months post port placement procedure, the catheter allegedly broken.There was no reported patient injury.

• Brand Name: M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F
• 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: 15903229
• MDR Text Key: 306451165
• Report Number: 3006260740-2022-05566
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0602833
• Device Catalogue Number: 0602833
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2022
• 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