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 Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported unit has been had issue with port needle line cracking.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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a crack in the infusion set was inconclusive due to the sample condition.Two photographs of the implicated 20g x 1¿ powerloc max infusion set were returned for evaluation.The y-site of the device was within frame of the photograph while the rest of the device was outside the frame of the photograph.An injection cap was attached to the y-site and an orange cap was partially attached to the injection cap.No cracks or damage were observable in the returned photographs.Microscopic examination and functional testing could not be conducted without the receipt of the physical sample.Therefore, the reported failure mode could not be confirmed, and a specific root cause could not be identified.Possible contributing factors for a leak at the connection could include a cracked luer adaptor or incompatibility with an interfacing device.If the physical sample is returned at a later date, this evaluation will be updated with the relevant information.A lot history review (lhr) of asgsfc059 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported unit has been had issue with port needle line cracking.No other information was provided.Additional information received 12/22/2022: it was reported by bd sales rep the cracks are occurring at the luer connector, where the needleless injection cap is attached.
Event or Problem Description
It was reported unit has been had issue with port needle line cracking.No other information was provided.Additional information received 12/22/2022: it was reported by bd sales rep the cracks are occurring at the luer connector, where the needleless injection cap is attached.
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.

• 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; parque industrial colonial; salt lake city 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15763884
• Report Number: 3006260740-2022-04522
• Device Sequence Number: 20397867
• Product Code: FPA
• UDI-Device Identifier: 00801741047350
• UDI-Public: (01)00801741047350
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 01/10/2023

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: 0132010
• Device Lot Number: ASGSFC059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 12/13/2022; 01/10/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/30/2022; 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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