MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX SAFETY INFUSION SET 20G X 1.0 INCH STRAIGHT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer that the luer connector is cracking.It has thought to be because we are screwing the caresite leur access device onto the tubing too hard.The majority of the time customer use the power loc max 20gx1in needle so i¿m unsure if the huber needle/tubing is having the same issue.Customer is thinking they are still using too much force when putting the caresite device on.
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 cracked y-site connector is confirmed; however, the exact cause is unknown.One photograph of a 20 g powerloc max with a y-site connector was returned for evaluation.An initial visual observation of the photograph showed a y-site connector and injection cap.The y-site connector appears to have a crack near the luer threads of the y-site.No further details of the crack could be seen in the returned photograph.The pinch clamp was engaged although no obvious use residue was observed.While the exact cause of the observed crack could not be determined from the returned photograph, possible causes include over-pressurization, exposure to incompatible chemicals, and excessive tightening.
Event or Problem Description
It was reported by the customer that the luer connector is cracking.It has thought to be because we are screwing the caresite leur access device onto the tubing too hard.The majority of the time customer use the power loc max 20gx1in needle so i¿m unsure if the huber needle/tubing is having the same issue.Customer is thinking they are still using too much force when putting the careseite device on.

• Brand Name: POWERLOC MAX SAFETY INFUSION SET 20G X 1.0 INCH STRAIGHT
• 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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17186525
• Report Number: 3006260740-2023-02573
• Device Sequence Number: 6249147
• Product Code: FPA
• UDI-Device Identifier: 00801741129735
• UDI-Public: (01)00801741129735
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K073050
• 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): 09/01/2023

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: CPA00029
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 09/07/2023
• 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