MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SMALL TITANIUM HICKMAN P; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602180
Medical Device Problem Codes	Fluid/Blood Leak (1250); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994); Swelling (2091)
Date of Event	07/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 08/2018).
Event or Problem Description
It was reported that approximately five years post placement of the port catheter via the right facial vein, during home infusion of saline, benefix and heparin the port was allegedly leaking externally.Reportedly, the health care provider administered tissue plasminogen activator (tpa).It was further reported that while performing the dye study, the patient experienced pain and swelling at the port site as the contrast medium leaked through the silicone septum of the port.It was further reported that the device was removed and replaced on the same day.The patient was reportedly stable after the removal and replacement of the device.
Event or Problem Description
It was reported that approximately five years post placement of the port catheter via the right facial vein, during home infusion of saline, benefix and heparin the port was allegedly leaking externally.Reportedly, the health care provider administered tissue plasminogen activator (tpa).It was further reported that while performing the dye study, the patient experienced pain and swelling at the port site as the contrast medium leaked through the silicone septum of the port.It was further reported that the device was removed and replaced on the same day.The patient was reportedly stable after the removal and replacement of the device.
Additional Manufacturer Narrative
Manufacturer 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: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged leaking port as no objective evidence has been provided to confirm any alleged deficiency with the port.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.The investigation for the leaking port is inconclusive.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: d4 (expiration date: 08/2018), g4.H11: g1, h6 (device code).

• Brand Name: SMALL TITANIUM HICKMAN P
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8907622
• Report Number: 3006260740-2019-02420
• Device Sequence Number: 19469820
• Product Code: LJT
• UDI-Device Identifier: 00801741025532
• UDI-Public: (01)00801741025532
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0602180
• Device Catalogue Number: 0602180
• Device Lot Number: REXH1177
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FACTOR CONCENTRATE; FACTOR CONCENTRATE; INTRAVENOUS IMMUNOGLOBULIN (IVIG); INTRAVENOUS IMMUNOGLOBULIN (IVIG); FACTOR CONCENTRATE; INTRAVENOUS IMMUNOGLOBULIN (IVIG)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 6 YR
• Patient Weight: 25