MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 22G X 1.0 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdrf050 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported that post port implant and during the usage of safety infusion set to access the port, two infusion sets have been found to break, leak and the clamps were not found to be working.There has been no reported patient injury.This report addresses the first device.
Additional 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) of asdrf050 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported that post port implant and during the usage of safety infusion set to access the port, two infusion sets have been found to break, leak and the clamps were not found to be working.There has been no reported patient injury.This report addresses the first device.Medwatch rcvd (b)(6)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).

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 22G X 1.0 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10279499
• Report Number: 3006260740-2020-02423
• Device Sequence Number: 14163466
• Product Code: FPA
• UDI-Device Identifier: 00801741047473
• UDI-Public: (01)00801741047473
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0142210
• Device Lot Number: ASDRF050
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1