MAUDE Adverse Event Report: 8.5 IN PRESSURE RATED MINIBORE SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MP5313-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: no product or photo was returned by the customer.The customer complaint of leaking at the mini bore extension connection could not be verified due to the product not being returned for failure investigation.A device history record review for model mp5313-c lot number 21036177 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: due to no sample received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that 2 8.5 in pressure rated minibore sets experienced leakage.The following information was provided by the initial reporter: yes it was the same lot number for the catheter.We had an incident last week which was also corrected by putting another extension set on.We thought it was a onetime occurrence.Yesterday i was inserting an iv that leaked as well when flushed.It looked to me that it was leaking at the extension connection, so i replaced it with a different type of extension set, max bore, as opposed to the mini bore.This corrected the leaking issue.
Event or Problem Description
It was reported that 2 8.5 in pressure rated minibore sets experienced leakage.The following information was provided by the initial reporter: yes it was the same lot number for the catheter.We had an incident last week which was also corrected by putting another extension set on.We thought it was a onetime occurrence.Yesterday i was inserting an iv that leaked as well when flushed.It looked to me that it was leaking at the extension connection, so i replaced it with a different type of extension set, max bore, as opposed to the mini bore.This corrected the leaking issue.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint of leaking at the mini bore extension connection could not be verified due to the product not being returned for failure investigation.A device history record review for model mp5313-c lot number 21036177 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 16mar2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: 8.5 IN PRESSURE RATED MINIBORE SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12375565
• Report Number: 9616066-2021-51902
• Device Sequence Number: 14470061
• Product Code: FPA
• UDI-Device Identifier: 50885403236714
• UDI-Public: 50885403236714
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/10/2021

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 Expiration Date: 03/16/2024
• Device Model Number: MP5313-C
• Device Catalogue Number: MP5313-C
• Device Lot Number: 21036177
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• 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