MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REP CONN, 8FR ORANGE; PORT AND CATHETER ACCESSORIES

Model Number	7712800
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
A lot history review could not be performed as the lot number was not provided.Although the sample was not returned for evaluation, two electronic photos were provided for review.The investigation is confirmed for connector detachment from catheter, as the photos showed an 8 fr groshong connector separated from the catheter.No damage on the connector, caps, catheter or over sleeve was apparent in the photos.The connector stylet was not visible in either photo.The definitive root cause could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model 7712800 port and catheter accessories allegedly experienced a detachment of device component.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) male patient was (b)(6).

• Brand Name: REP CONN, 8FR ORANGE
• Common Device Name: PORT AND CATHETER ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8822596
• Report Number: 3006260740-2019-02179
• Device Sequence Number: 14209892
• Product Code: LJS
• UDI-Device Identifier: 00801741087028
• UDI-Public: (01)00801741087028
• 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): 07/24/2019

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: 7712800
• Device Catalogue Number: 7712800
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1