MAUDE Adverse Event Report: EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2N1333
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: this event occurred during the unspecified date of (b)(6) 2021.Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of non-dehp standard bore catheter extension sets were ¿block/clogged¿ and would not flow.It was further reported that it was impossible to empty the sets unless by injecting liquid with an unspecified syringe by applying strong pressure on the plunger.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the device was not received for evaluation; therefore, a device analysis could not be completed.However, the condition of no flow, as reported in the event description, was determined to be a machine related issue during the manufacturing process.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12460393
• Report Number: 1416980-2021-05618
• Device Sequence Number: 11743567
• Product Code: FPA
• UDI-Device Identifier: 00085412475394
• UDI-Public: (01)00085412475394
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K132734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: Other
• Device Catalogue Number: 2N1333
• Device Lot Number: UR21B23037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/13/2021
• Date Device Manufactured: 02/25/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED SYRINGE.; UNSPECIFIED SYRINGE