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

Catalog Number 0606150J

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Difficult or Delayed Separation (4044)

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

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the titanium low-profile implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, groshong single-lumen, 8f are identified in common device name and pma/510k.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that after the port placement procedure, sheath was put into the water to test, it was found that the air was allegedly mixed.It was further reported that the peel away sheath allegedly had split at the base.There was no patient contact.

Event Description

It was reported that after the port placement procedure, sheath was put into the water to test, it was found that the air was allegedly mixed.There was no patient contact.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium low-profile implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, groshong single-lumen, 8f are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: three samples were returned for evaluation.Upon review only one sample was reported defective.Functional, gross visual and microscopic visual evaluations were performed.Although the sample was returned for evaluation, three electronic photos were provided for review.The investigation is confirmed for the identified fracture issue, as a small hole, was noted between the center of the t-handle.The investigation is unconfirmed for the reported fluid leak issue, as no leaks were noted coming out of what appeared like an open hole.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.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 LOW-PROFILE IMPLANTABLE PORT, GROSHONG 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15181129
• MDR Text Key: 304909363
• Report Number: 3006260740-2022-03080
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098253
• UDI-Public: (01)00801741098253
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0606150J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2022
• 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