MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported that port a cath tubing broke at the site where tubing connects to hub.Completely broke apart.Additional information received.: the event did not occur during a life-threatening or urgent medical situation.The break was discovered during routine inspection.Normal saline was used but nothing was infusing at the time of event.Patient had to be deaccessed and reaccessed.Port access is a very stressful procedure for the pediatric population causing unnecessary distress.
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 complaint of a split extension tubing was confirmed and the cause is currently under investigation.The product returned for evaluation was one 20 ga powerloc max infusion set.The returned product sample was evaluated and the following observations were made: ¿ a complete break in the extension tube was confirmed and occurred at the interface of the proximal luer adapter ¿ the fracture surfaces of the damage contained striation-like patterns which were indicative of flexural fatigue based failures, which may have been a contributing factor to the extension tubing damage.Repetitive mechanical stresses such as twisting and kinking may have contributed to the observed event; however, it appeared that additional unidentified factors also contributed.The device is a supplied component and the supplier has been notified of this event.
Event or Problem Description
It was reported that port a cath tubing broke at the site where tubing connects to hub.Completely broke apart.Additional information received.: the event did not occur during a life-threatening or urgent medical situation.The break was discovered during routine inspection.Normal saline was used but nothing was infusing at the time of event.Patient had to be deaccessed and reaccessed.Port access is a very stressful procedure for the pediatric population causing unnecessary distress.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 1 IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17038692
• Report Number: 3006260740-2023-02192
• Device Sequence Number: 6393248
• Product Code: FPA
• UDI-Device Identifier: 00801741047923
• UDI-Public: (01)00801741047923
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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: 0672010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown