MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the use of safestep 20ga x 1 in.Needle caused a patient to be hospitalized with bacteremia and subsequent port replacement.

Event Description

It was reported that the use of safestep 20ga x 1 in.Needle caused a patient to be hospitalized with bacteremia and subsequent port replacement.Medwatch rcvd 09/15/2020: patient reported that huber powerloc needle line is splitting.She switched to safestep, which was also splitting.Then a recall on these products was released.The patient developed swelling and a lump at her port site.She then developed fever and was hospitalized.Her port is being removed and a midline will iv will be placed so that she receive iv antibiotics.More information to follow after she is released from the hospital and we can get a full time line of events and lot numbers.Huber powerloc 22gx1 (lot# ascyf018, ascyf019, asczf026, asdrf047, asdrf048, asdrf049, asdrf050) huber safestep 22x0.5 (lot# ascyf013, ascyf014, asczf029, ascvf035, ascvf038, ascvf042); huber safestep 22x1 (lot# asdnf034, asdnf049, asdnf055, asdpf015, asdpf017, asdpf024, asdpf025, asdpf026, asdqf017, asdrf066, asdrf066, asduf120, asdvf004, asdvf009, asdvf013, asdvf016, asdvf025).

Manufacturer Narrative

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.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 1 IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10518492
• MDR Text Key: 206476027
• Report Number: 3006260740-2020-03214
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066221
• UDI-Public: (01)00801741066221
• Combination Product (y/n): N
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0032
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention