MAUDE Adverse Event Report: 8.5 IN PRESSURE RATED SET W/BONDED; INTRAVASCULAR ADMINISTRATION SET

Model Number	MP5312-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 21055044, medical device expiration date: 05/07/2026, device manufacture date: 04/26/2021.Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.The customer's address is unknown.Unknown, (b)(6) usa has been used as a default.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported 8.5 in pressure rated set w/bonded had leakage issues.The following information was provided by the initial reporter: "we have been having these leak at the hub where attached to iv tubing.".
Additional Manufacturer Narrative
H6: investigation summary: no photo or sample was provided for investigation.Without photo or sample, the customer's complaint of leakage cannot be verified and the root cause remains unknown.A device history record review for model mp5312- c lot number 21055044 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07may2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported 8.5 in pressure rated set w/bonded had leakage issues.The following information was provided by the initial reporter: "we have been having these leak at the hub where attached to iv tubing.".

• Brand Name: 8.5 IN PRESSURE RATED SET W/BONDED
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12418866
• Report Number: 9616066-2021-51948
• Device Sequence Number: 19995764
• Product Code: FPA
• UDI-Device Identifier: 50885403230156
• UDI-Public: 50885403230156
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/17/2021

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 Model Number: MP5312-C
• Device Catalogue Number: MP5312-C
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 10/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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