MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0607302CE

Device Problems Burst Container or Vessel (1074); Difficult to Flush (1251); Fracture (1260); Stretched (1601); Suction Problem (2170); Obstruction of Flow (2423); Material Protrusion/Extrusion (2979)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

It was reported that two years five months and twenty-three days post a port placement, the port was allegedly blocked after flushing the port.It was further reported that the catheter showed a break and when they flush it, it allegedly ballooned because the catheter was blocked.Additionally, it was reported that the port was allegedly unable to aspirate and had flushing issue.Reportedly, the port was removed.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the titanium implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the titanium implantable port, chronoflex single-lumen, 6f products are identified in d2 and g4.As the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 11/2024).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.Device pending return.

Event Description

It was reported that two years five months and fifteen days post a port placement, the port was allegedly blocked after flushing the port.It was further reported that the catheter allegedly showed a break and when flushed, it allegedly ballooned because the catheter was blocked.Furthermore, the port was allegedly unable to aspirate and there was difficulty in flushing the catheter.Reportedly, the port was removed.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the titanium implantable port, chronoflex single-lumen, 6f products are identified in d2 and g4.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 catheter segment was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.Stretching was observed to the catheter from ballooning and a kink was noted to the catheter.Catheter wear was noted throughout the catheter segment.What appeared to be deflation, was noted on the center portion of the catheter segment which appeared to be burst.Upon infusion, ballooning was observed at the center portion of the catheter segment while drops of water exited the distal end.Aspiration was attempted and was unsuccessful.Therefore, the investigation is confirmed for the reported material protrusion, stretched, suction problem, difficult to flush and identified burst issues.However the investigation is inconclusive for the reported obstruction issue as the affected port was not returned for evaluation.Also the investigation is unconfirmed for the reported fracture issue as no visible cracks or break were noted.A definitive root cause could not be determined based upon the 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: 11/2024), g3.H6 (device) h11: b3, b5, 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.

• Brand Name: TITANIUM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19056549
• MDR Text Key: 339774418
• Report Number: 3006260740-2024-01530
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K050310
• 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: 05/08/2024

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: 0607302CE
• Device Lot Number: REFR0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/06/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/10/2024
• 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 Age: 69 YR
• Patient Sex: Female