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

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that while de-accessing a patient's port, the base of the port got stuck halfway through the shaft of the needle.This resulted in not being able to use the safety mechanism, which means there was a potential for the team member needle stick and also patient discomfort due to difficult de-accessing the port.
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 while de-accessing a patient's port, the base of the port got stuck halfway through the shaft of the needle.This resulted in not being able to use the safety mechanism, which means there was a potential for the team member needle stick and also patient discomfort due to difficult de-accessing the port.
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 difficulty advancing the safety mechanism is confirmed and was determined to be related to the supplier.One 22 ga x 1.0 in.Powerloc max infusion set without a y-site was returned for evaluation.An initial visual observation showed use residues along the returned infusion set.The safety mechanism was advanced over the needle tip upon the return of the device.A microscopic observation revealed a ring of excessive adhesive along the metal cannula just proximal of the safety mechanism.Excessive adhesive was also observed where the needle and the needle housing interface.Using a uv light, the ring of adhesive was visible around the metal cannula just proximal of the safety mechanism.Because excessive adhesive was found along the safety mechanism, the complaint of difficulty advancing the safety mechanism is confirmed and was determined to be supplier related.This complaint will be recorded for future trending and monitoring purposes.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the supplier to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h11.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18190472
• Report Number: 3006260740-2023-05287
• Device Sequence Number: 20663324
• Product Code: FPA
• UDI-Device Identifier: 00801741047442
• UDI-Public: (01)00801741047442
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• 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): 02/27/2024

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: Health Professional
• Device Expiration Date: 09/25/2025
• Device Model Number: N/A
• Device Catalogue Number: 0142010
• Device Lot Number: ASGWFC111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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