MAUDE Adverse Event Report: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asevf073 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (asevf073) have been reported from the same facility.
Event or Problem Description
It was reported the ct power injectors pressuring out.What they¿re being treated for: cholangiocarcinoma of the liver, no pt.Harm.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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of the ct power injector pressuring out during ct injection was inconclusive because the device was fully occluded and the pressure/volumetric flowrate relationship could not be characterized.The product returned for evaluation was one 20ga x 1¿ powerloc max safety infusion set.Usage residues were observed throughout the sample and the safety mechanism was engaged.Crystalline precipitate was observed within the extension tubing.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be fully occluded by the precipitate within the extension tubing.Microscopic inspection of the sample confirmed the presence of occluding precipitate but was otherwise unremarkable.The presence of occluding precipitate suggest that residue buildup within the deivce may have contributed to the reported event; however, the lack of ability to test the sample under power injection prevented confirmation of the reported event.Consequently this complaint is inconclusive at this time.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported the ct power injectors pressuring out.What they¿re being treated for: cholangiocarcinoma of the liver, no pt.Harm.No other information was provided.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12370838
• Report Number: 3006260740-2021-03521
• Device Sequence Number: 17172569
• Product Code: FPA
• UDI-Device Identifier: 00801741047442
• UDI-Public: (01)00801741047442
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: 0142010
• Device Lot Number: ASEVF073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2020
• 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 Age: 79 YR
• Patient Weight: 76