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

Catalog Number 0603880C

Device Problems Backflow (1064); Fracture (1260); Material Separation (1562); Obstruction of Flow (2423); Material Protrusion/Extrusion (2979); Migration (4003)

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

Event Date 07/11/2023

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, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiry date: 10/2025).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 : device not returned.

Event Description

It was reported that one month and fourteen days post-port placement, the infusion tube was allegedly not smooth and swelling was visible around the base of the infusion port.It was further reported that liquid regurgitation was observed at the eye of the injection needle.It was also reported that a chest radiograph examination indicated that the chest tube was tortuously placed and that both ends were at the right anterior fifth and sixth anterior intercoatal space levels.Furthermore, the pipeline at the infusion port had fallen off.The transfusion pipeline was removed, and the base of the infusion port was removed under local anesthesia.During the procedure, it was found that the base of the infusion port and the connector still existed, and the stump of the catheter was visible after the connector was removed, with the length of the stump being about 0.3cm and the broken edge being irregular.The current status of the patient was unknown.

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, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f 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 bard implantable port and one cath-lock was returned for evaluation.Gross visual, microscopic, dimensional and functional evaluations were performed on the returned device.A catheter segment, was noted on the port stem of the port body.The edges of both end of the catheter segment returned were noted to be uneven and the surface on both ends of the catheter segment were noted to be granular.Therefore, the investigation is confirmed for the reported fracture and material separation issues.However, the investigation is inconclusive for the reported backflow and migration issues as the exact circumstance at the time of the event reported was unknown.The 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 (expiration 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.

Event Description

It was reported that one month and fourteen days post-port placement, the infusion tube was allegedly not smooth and swelling was visible around the base of the infusion port.It was further reported that liquid regurgitation was observed at the eye of the injection needle.It was also reported that a chest radiograph examination indicated that the chest tube was tortuously placed and that both ends were at the right anterior fifth and sixth anterior intercostal space levels.Furthermore, the pipeline at the infusion port had fallen off.The transfusion pipeline was removed, and the base of the infusion port was removed under local anesthesia.During the procedure, it was found that the base of the infusion port and the connector still existed, and the stump of the catheter was visible after the connector was removed, with the length of the stump being about 0.3cm and the broken edge being irregular.The current status of the patient is unknown.

• Brand Name: HICKMAN 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: 17681166
• MDR Text Key: 322606902
• Report Number: 3006260740-2023-03890
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111167
• UDI-Public: (01)00801741111167
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K924250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

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 Catalogue Number: 0603880C
• Device Lot Number: REGY2378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 12/23/2023
• Supplement Dates FDA Received: 12/28/2023
• 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