MAUDE Adverse Event Report: POWERLOC PORT ACCESS KIT 20G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reey3028 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the item has come in damaged.Additional information received 05/26/2021: "port a cath tubing was leaking at a random spot in the tubing.Needed to deaccess port and reaccess port with new tubing.".
Event or Problem Description
It was reported the item has come in damaged.Additional information received on 05/26/2021: "port a cath tubing was leaking at a random spot in the tubing.Needed to deaccess port and reaccess port with new tubing.".
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 luer hub was confirmed and the cause was supplier-related.The product returned for evaluation was one 19ga x 1¿ powerloc safety infusion set with y-site.Usage residues were observed throughout the sample and needleless injection caps were attached to both luer adapters.A crack was observed in the y-site, opposite the molding gate.The crack appeared to originate at the luer orifice and propagated along a molding weld line in the material.Microscopic inspection of the y-site confirmed that the crack propagated along a weld line feature in the material.The crack exhibited a granular fracture surface.Abundant superficial stress fracturing was observed throughout the region of the y-site near the orifice.The crack occurred along a molding feature in the y-site material.The abundant stress fracturing was also indicative of material embrittlement, likely caused by manufacturing conditions.The device is a supplied component and the supplier has been notified of this event.

• Brand Name: POWERLOC PORT ACCESS KIT 20G X 1 IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12009781
• Report Number: 3006260740-2021-02322
• Device Sequence Number: 14279013
• Product Code: FPA
• UDI-Device Identifier: 00801741044540
• UDI-Public: (01)00801741044540
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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: 2672010
• Device Lot Number: REEY3028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 09/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other