MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX PORT ACCESS KIT 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2142075
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged infusion set was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 0.75¿ powerloc max safety infusion set.The sample appeared free of obvious usage residues and the sample was received with the safety mechanism not engaged.A partially circumferential split was observed at the junction between the luer adapter and the extension tubing.Tactile inspection of the sample revealed tensile weakness in the vicinity of the split.Microscopic inspection of the split revealed a granular fracture surface.Beach marks were evident in the fracture surface.Deformation was observed at the corners of the split and the deformation was more severe on one side.The fracture features were consistent with fatigue failure caused by device manipulation.The uneven deformation suggested that torsional (twisting) stress contributed to the observed damage.The event description appeared to confirm that the sample was intentionally manipulated to failure.A lot history review (lhr) of rebx1896 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that this device was removed from the supply cabinet for quality testing purposes; it was never used on a patient.After being manipulated for a few minutes, the distal end of the tubing where it attaches to the luerlock connector cracked.

• Brand Name: POWERLOC MAX PORT ACCESS KIT 20G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7584364
• Report Number: 3006260740-2018-01304
• Device Sequence Number: 2282129
• Product Code: FPA
• UDI-Device Identifier: 00801741044298
• UDI-Public: (01)00801741044298
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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: 2142075
• Device Catalogue Number: 2142075
• Device Lot Number: REBX1896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1