MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "attending peds on day unit for treatment accompanied by mother.Ivad had been accessed previously on february 17th for ongoing treatment.The nurse caring for the patient assessed the line prior to giving chemotherapy by checking for blood return and noted that only air returned in the syringe, no blood return or fluid return; suspected invisible break in line.Break in tubing verified once the affected huber needle was removed and examined.The break was found where the microbore tubing of the ivad needle extension set meets the light blue luer connection." it was stated this occurred two times.This report addresses the first device.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of asezf117 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (asezf117) have been reported from the same facility in (b)(6).
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 a damaged infusion set was confirmed and the cause is currently under investigation.The product returned for evaluation was one 19ga x 0.75" powerloc max safety infusion set.The returned product sample was evaluated and the following observations were made: a tear in the extension tube was seen at the interface of the proximal luer adapter the fracture surfaces of the damage contained striation-like patterns, radiating tear marks and material buckling which were indicative of flexural fatigue based failures, which may have been a contributing factor to the extension tubing damage.Repetitive mechanical stresses such as twisting and kinking may have contributed to the observed event; however, it appeared that additional unidentified factors also contributed.The device is a supplied component and the supplier has been notified of this event.H3 other text: evaluation findings are in section h.11.
Event or Problem Description
It was reported "attending peds on day unit for treatment accompanied by mother.Ivad had been accessed previously on (b)(6) for ongoing treatment.The nurse caring for the patient assessed the line prior to giving chemotherapy by checking for blood return and noted that only air returned in the syringe, no blood return or fluid return; suspected invisible break in line.Break in tubing verified once the affected huber needle was removed and examined.The break was found where the microbore tubing of the ivad needle extension set meets the light blue luer connection." it was stated this occurred two times.This report addresses the first device.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN
• 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: 14398208
• Report Number: 3006260740-2022-01777
• Device Sequence Number: 5326079
• Product Code: FPA
• UDI-Device Identifier: 00801741047435
• UDI-Public: (01)00801741047435
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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: 0141975
• Device Lot Number: ASEZF117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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