MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX I POWER-INJECTABLE INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 19 GAUGE X .75 IN.

Device Problems Retraction Problem (1536); Fail-Safe Problem (2936)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2016

Event Type  malfunction  

Event Description

After treatment, flushed implanted port and attempted to de-access port and safety device would not retract.Informed patient that safety device did not work but this would not affect her, safety device is to prevent nursing staff from needle stick.

• Brand Name: POWERLOC MAX I POWER-INJECTABLE INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 5642868
• MDR Text Key: 44794054
• Report Number: 5642868
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/01/2019
• Device Model Number: 19 GAUGE X .75 IN.
• Device Catalogue Number: 0141975
• Device Lot Number: ASAPS007
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2016
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1