MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 22G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that when flushing the needle after drug was infused the nurse saw the leak on the plastic hub.
Event or Problem Description
It was reported that when flushing the needle after drug was infused the nurse saw the leak on the plastic hub.
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a cracked y-site was confirmed and the cause was supplier-related.The product returned for evaluation was one 22ga x 0.75¿ powerloc safety infusion set with y-site.Usage residues were observed throughout the sample.A longitudinally aligned split was observed in the y-site.Microscopic inspection of the split revealed a granular fracture surface.Discoloration and abundant superficial stress cracking were observed in the vicinity of the split.The split propagated along a molding weld line.The split propagated along a molding feature, indicating that features created during the molding process caused the observed fracturing.The stress fracturing observed further suggested that some part of the manufacturing process affected the mechanical properties of the y-site material.The device is a supplied component and the supplier has been notified of this event.The supplier has implemented actions to address this type of component failure and the device was manufactured prior to that implementation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: POWERLOC SAFETY INFUSION SET 22G X 0.75IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10257161
• Report Number: 3006260740-2020-02344
• Device Sequence Number: 19627800
• Product Code: FPA
• UDI-Device Identifier: 00801741047978
• UDI-Public: (01)00801741047978
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2020

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: 0672234
• Device Lot Number: UNK-F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1