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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
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, "port accessed with needle 1¿ bard powerloc max 20g on 3/7/23 1911 by dch.Multiple ivs infusing through port needle.On (b)(6) 2023 patient with iv with bicarb infusing via port, at 12:20 rn went to draw labs (48 hr metrotrexate), rn noted line leaking, attempted to draw blood cultures, but only air returned, blood dripping from line, port de-accessed.Port tubing totally disconnected from blue connection piece.Blood cultures drawn and negative.".
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 that the tubing detached from the luer adaptor was confirmed but the cause is unknown.A single photograph of a damaged infusion set was returned for evaluation.The implicated product was a 20g x 1¿ powerloc max safety infusion set.A needleless injection cap was attached to the luer adaptor and red residual material was seen within the device, indicating that the device had been used.The tubing was completely detached from the luer adaptor.It could not be determined from the photograph if the tubing had dislodged from the luer adaptor or if a complete circumferential split was present in the tubing.The end of the tubing appeared compressed, which may be indicative or kinking or torsion of the tubing near the break/dislodgement.However, this could not be independently confirmed without examination of the physical sample.In addition, microscopic observation and tactile evaluation could not be performed without the physical device.The observable features on the submitted photograph did not contain enough information to identify a specific root cause of the reported event.Possible contributing factors could include tensile (pulling) damage, material fatigue, or damage from a sharp instrument.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by the customer that, "port accessed with needle 1¿ bard powerloc max 20g on (b)(6) 2023 1911 by dch.Multiple ivs infusing through port needle.On (b)(6) 2023, patient with iv with bicarb infusing via port, at 12:20 rn went to draw labs (48 hr metrotrexate), rn noted line leaking, attempted to draw blood cultures, but only air returned, blood dripping from line, port de-accessed.Port tubing totally disconnected from blue connection piece.Blood cultures drawn and negative.".

• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16843769
• Report Number: 3006260740-2023-01607
• Device Sequence Number: 20555213
• Product Code: FPA
• UDI-Device Identifier: 00801741047442
• UDI-Public: (01)00801741047442
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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 Expiration Date: 04/14/2025
• Device Model Number: N/A
• Device Catalogue Number: 0142010
• Device Lot Number: ASGRF064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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