MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0606150

Device Problems Unsealed Device Packaging (1444); Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007)

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

Event Date 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

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 bardport titanium l/p implantable port kit in its inner packaging was returned for evaluation and one electronic video was provided for review.Gross visual evaluation was performed on the returned device.The investigation is confirmed for the reported unable to open sterile packaging and identified unsealed device packaging and packaging problem issues as the clinician was unable to open the device package in the provided video and further seal transfer was noted along the lip of the outer tray and the package was noted to be crushed.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.(expiry date: 03/2026).

Event Description

It was reported that prior to a port implant procedure, the device allegedly had difficulty in opening the package.It was further reported that, there is a resistance due to its glue in the package itself.There was no patient contact.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SL
• 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: 14903816
• MDR Text Key: 298028167
• Report Number: 3006260740-2022-02507
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026058
• UDI-Public: (01)00801741026058
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0606150
• Device Catalogue Number: 0606150
• Device Lot Number: REFS3729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2021
• 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