MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TITANIUM LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0606150J

Device Problems Break (1069); Fluid/Blood Leak (1250); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was not provided, therefore, a lot history review could not be performed.The device was returned to the manufacturer for evaluation and a photo was provided for review.Therefore, the investigation of the reported event is currently underway.The device is labeled for single use.The catalog number identified has not been cleared in the u.S., but is similar to the titanium low-profile implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code for the titanium low-profile implantable port, groshong single-lumen, 8f is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicates the model 0606150j implanted ports allegedly experienced break and fluid leak.The report was received from a single source.This malfunction involved patient with no known impact to the patient.The female patient is (b)(6) years old and weighs (b)(6) kgs.

Event Description

This report summarizes one malfunction.A review of the reported information indicates the model 0606150j implanted ports allegedly experienced break, stretched material and fluid leak.The report was received from a single source.This malfunction involved with no known impact to the patient.The female patient is 90 years old and weighs 32 kgs.

Manufacturer Narrative

H10: the lot number for the reported malfunction was not provided, therefore, a lot history review could not be performed.The device was returned to the manufacturer for evaluation and photos are provided and reviewed.The investigation is confirmed for cath-lock damage as scoring and tool damage were identified on the cath-lock.However, the investigation is inconclusive for leakage issues.The root cause could not be determined.The device is labeled for single use.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 for the titanium low-profile implantable port, groshong single-lumen, 8f is identified in d2.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): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10744365
• MDR Text Key: 213931900
• Report Number: 3006260740-2020-03525
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098253
• UDI-Public: (01)00801741098253
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0606150J
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1