MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. SAFESTEP HUBER NEEDLE SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number LH-0029

Device Problems Bent (1059); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 01/13/2018

Event Type  malfunction  

Event Description

Patient admitted from ed; cap fell off.De-accessed and re-accessed.Had to attempt re-access x3 due to port needles being bent.Two needles were saved.Third attempt was successful.

• Brand Name: SAFESTEP HUBER NEEDLE SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 7244164
• MDR Text Key: 99127868
• Report Number: 7244164
• 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: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/28/2019
• Device Model Number: LH-0029
• Device Catalogue Number: LH-0029
• Device Lot Number: ASAYS0105
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2018
• 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
• Treatment: NOT KNOWN.