MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 WINGED INFUSION SET 20G X 0.75IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

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	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refu1294 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported patient contacted nursing team to advise them that her portacath needle line had fractured.Nursing team advised patient to clamp the line above where the fracture was located to ensure that nothing was able to enter the line.Patient booked to attend facility on the same day and the port needle was removed.Patient reviewed by the medical team.Patient's portacath was re-accessed safely, and their iv antibiotic treatment has resumed.
Event or Problem Description
It was reported patient contacted nursing team to advise them that her portacath needle line had fractured.Nursing team advised patient to clamp the line above where the fracture was located to ensure that nothing was able to enter the line.Patient booked to attend facility on the same day and the port needle was removed.Patient reviewed by the medical team.Patient's portacath was re-accessed safely, and their iv antibiotic treatment has resumed.
Additional Manufacturer Narrative
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), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a breach in the infusion set was confirmed but the cause of the damage could not be determined from the photograph that was provided for investigation.The photo showed a winged infusion set that exhibited evidence of use.A stream of clear fluid was observed to exit from the extension set tubing at the distal end of the luer adaptor.The characteristics of the leak path in the tubing could not be discerned from the photo.While a breach in the tubing was confirmed, there were no distinguishing features that could aid in identifying a specific root cause.

• Brand Name: WINGED INFUSION SET 20G X 0.75IN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13191821
• Report Number: 3006260740-2021-05554
• Device Sequence Number: 6045611
• Product Code: FMI
• UDI-Device Identifier: 00801741065804
• UDI-Public: (01)00801741065804
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K863606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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: 0604190
• Device Lot Number: REFU1294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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