MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Restricted Flow rate (1248)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

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 pressure/volumetric flowrate relationship could not be characterized.The product returned for evaluation was one 20ga x 0.75¿ powerloc 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 patent to infusion and aspiration with no observed leaks.The effort required to flush the sample was comparable to that required when flushing a similar non-complainant device.Microscopic inspection of the sample was unremarkable.The presence of precipitate suggest that residue buildup within the device 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.A lot history review (lhr) of asfnf007 showed four other similar product complaint(s) from this lot number.The complaints for this lot number (asfnf007) have been reported from the same facility.

Event Description

It was reported ct power injector pressuring out.Additional information received 09/07/2021: "what they¿re being treated for: malignant neoplasm of the pancreas, unspecified location of malignancy.Was there any patient harm reported? no, patient was not harmed.".

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12526424
• MDR Text Key: 273128755
• Report Number: 3006260740-2021-03966
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047763
• UDI-Public: (01)00801741047763
• Combination Product (y/n): N
• PMA/PMN Number: K060812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0652034
• Device Lot Number: ASFNF007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 132