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

Catalog Number 0607540CE

Device Problems Unsealed Device Packaging (1444); Component Missing (2306)

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

Event Date 07/05/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number has not been cleared in the us but is similar to the x-port isp implantable port, chronoflex single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, chronoflex single-lumen, 8f are identified.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.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2023).

Event Description

It was reported that prior to port placement, double-wrapped box was empty.It was further reported that the packaging allegedly had no seal.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one unsealed x-port mri implantable port kit was returned for evaluation and three electronic photos were provided for review.Visual evaluation was performed.The inner package of the sample arrived unsealed.Ifus, id cards, implant record cards and product specifications were received within package.No components were available inside the inner package.However, the investigation is inconclusive for the reported component missing and unsealed device package issues as the package was returned unsealed and the exact circumstances at the time of the reported event are unknown and the provided photos are not sufficient enough to confirm the issue.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: the catalog number identified in section d4 has not been cleared in the us but is similar to the x-port isp implantable port, chronoflex single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, chronoflex single-lumen, 8f are identified in d2 and g4.H10: d4 (expiry date: 01/2023).H11: section a through f ¿ the information provide 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.H3 other text : see h10.

Event Description

It was reported that prior to port placement, double-wrapped box was empty.It was further reported that the packaging allegedly had no seal.There was no patient contact.

• Brand Name: X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12265186
• MDR Text Key: 264695708
• Report Number: 3006260740-2021-03083
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K022983
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0607540CE
• Device Lot Number: REFP2328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2021
• 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): Other