MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SLIMPORT IMPLANTABLE PORT, DUAL-LUMEN ROSENBLATT, 7F; PORT & CATHETER, IMPLANED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0604970
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 07/2026).
Event or Problem Description
It was reported that sometime post a port placement procedure, the port allegedly leaked while flushing.It was further reported that the port was removed and the procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
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 slimport l/p dual lumen implantable port attached to a catheter segment was returned for evaluation.Gross, microscopic visual and functional testing were performed.A complete circumferential break was noted on the distal end of the attached catheter and the edges of the complete circumferential break were noted to be uneven.Upon infusion of the right port septa, pressure was felt while water exited the distal end.Aspiration was attempted but was unsuccessful.Infusion and aspiration test was performed on the left port septa and was successful.Therefore the investigation is inconclusive for the reported fluid leak issue as the exact circumstances at the time of reported event cannot be verified from the returned physical sample.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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: d4 (expiry date: 07/2026).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.
Event or Problem Description
It was reported that during a port placement procedure, the port allegedly leaked while flushing.It was further reported that the port was removed and the procedure was completed using another device.There was no reported patient injury.

• Brand Name: SLIMPORT IMPLANTABLE PORT, DUAL-LUMEN ROSENBLATT, 7F
• Common Device Name: PORT & CATHETER, IMPLANED, 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: 16245180
• Report Number: 3006260740-2023-00125
• Device Sequence Number: 17755828
• Product Code: LJT
• UDI-Device Identifier: 00801741025884
• UDI-Public: (01)00801741025884
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K964066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0604970
• Device Catalogue Number: 0604970
• Device Lot Number: REGV2783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Unknown