MAUDE Adverse Event Report: BARD ACCESS SYSTEMS X-PORT LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F

Model Number	0655870
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided and a lot history review will be performed.The sample was returned to the manufacturer for inspection/evaluation.The company is still investigating the issue at this time.The device was labeled for single use.(method, results, conclusion).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that the model 0655870 implantable port allegedly experienced guidewire missing.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.The patient's age, sex and weight were unknown.
Additional Manufacturer Narrative
H10: the lot number for the reported malfunction was provided, therefore, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation is inconclusive for missing accessory issue.A definitive root cause could not be determined based upon available information.The device was 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 the model 0655870 implantable port allegedly experienced guidewire missing.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.The patient's age, sex and weight were unknown.

• Brand Name: X-PORT LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10738073
• Report Number: 3006260740-2020-03487
• Device Sequence Number: 1127267
• Product Code: LJT
• UDI-Device Identifier: 00801741026331
• UDI-Public: (01)00801741026331
• 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): 01/07/2021

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: 0655870
• Device Catalogue Number: 0655870
• Device Lot Number: RECW0334
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 01/07/2021
• Patient Sequence Number: 1