MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SUB-Q PORT PERITON (NO C; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0603006
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged allergic reaction as no objective evidence has been provided to confirm any alleged deficiency with the port/catheter.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include patient allergies; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).The investigation for the allergic reaction is inconclusive.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that part of a model 0603006 port & catheter was allegedly not removed by physician.It was further reported that patient allegedly developed an allergic reaction to the catheter.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.

• Brand Name: SUB-Q PORT PERITON (NO C
• 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: 8800099
• Report Number: 3006260740-2019-01987
• Device Sequence Number: 16779360
• Product Code: LJT
• UDI-Device Identifier: 00801741025792
• UDI-Public: (01)00801741025792
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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: No Information
• Device Model Number: 0603006
• Device Catalogue Number: 0603006
• Device Lot Number: RESA0344
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/17/2019
• Patient Sequence Number: 1