MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by customer nurse states they had a patient safety issue the other day with this product.One of our patients was receiving continuous chemotherapy and was at home when the y-site on the tubing of her port needle detached and completely separated.Additional information received 23-jul-2024: the patient had to stop their continuous chemo and come in to get a new bag started.This had a patient impact and caused delays in treatment.No other information was provided.
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 detached extension tube was confirmed and was determined to be supplier related.The product returned for evaluation was a 20ga x 0.75¿ powerloc max infusion set.Usage residues were observed throughout the sample and the safety mechanism was engaged.An injection cap was attached to the luer adapter.The extension tube was observed to be completely detached from the y-site.An attempt to stretch the extension tube revealed slight tensile weakness when compared to a non-complainant infusion set.Microscopic inspection of the surface of the proximal extension tubing confirmed that it had detached from the y-site and was unbroken.Inspection under an ultraviolet light revealed fluorescing adhesive residue on the luer adapter and extension tubing.The observed detachment was likely caused by failure of the bond between the proximal extension tubing and the y-site.Possible causes of the bond failure include insufficient adhesive deposition or curing.The device is a supplied component and the supplier has been notified of this event.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer nurse states they had a patient safety issue the other day with this product.One of our patients was receiving continuous chemotherapy and was at home when the y-site on the tubing of her port needle detached and completely separated.Additional information received 23-jul-2024: the patient had to stop their continuous chemo and come in to get a new bag started.This had a patient impact and caused delays in treatment.No other information was provided.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN 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 UT 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19997553
• Report Number: 3006260740-2024-04513
• Device Sequence Number: 20640611
• Product Code: FPA
• UDI-Device Identifier: 00801741047947
• UDI-Public: (01)00801741047947(11)240621(17)270729(10)ASJNFC189
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/12/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0672034
• Device Lot Number: ASJNFC189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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