MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SUB-Q PORT PERITON (NO C; IMPLANTABLE PORT

Model Number	0603006
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that cath-lock over sleeve of a model 0603006 implantable port allegedly disconnected.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient was reported to be a (b)(6) year-old female, weight was not reported.
Additional Manufacturer Narrative
The device was returned for evaluation.Electronic photos and x-rays were also provided for evaluation.The investigation was confirmed for catheter lock sleeve detachment.A root cause has not been determined.The device is labeled for single use.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
This report summarizes one malfunction.A review of the reported information indicated that cath-lock over sleeve of a model 0603006 implantable port allegedly disconnected.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient was reported to be a 37-year-old female, weight was not reported.

• Brand Name: SUB-Q PORT PERITON (NO C
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8822138
• Report Number: 3006260740-2019-02160
• Device Sequence Number: 2541005
• 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,Followup
• Report Date (Section B): 10/10/2019

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: RECR0172
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1