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

Model Number	MP5313-C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 4 8.5 in pressure rated minibore sets experienced leakage.The following information was provided by the initial reporter: several nurses reported leakage from the 22ga iv cath to the extension set.I had the iv nurse put one together in front of me and no leakage was detected.I also have the packaging from the product that did and the lot numbers are the same.I asked if they made sure the connection was screwed tightly and she confirmed it was and also informed me this happened to four other nurses.She told me they went through several extension sets before they found one that didn¿t leak.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint of leakage from 22ga iv catheter to the extension set could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.A device history record review could not be performed on model mp5313-c because a valid lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 4 8.5 in pressure rated minibore sets experienced leakage.The following information was provided by the initial reporter: several nurses reported leakage from the 22ga iv cath to the extension set.I had the iv nurse put one together in front of me and no leakage was detected.I also have the packaging from the product that did and the lot numbers are the same.I asked if they made sure the connection was screwed tightly and she confirmed it was and also informed me this happened to four other nurses.She told me they went through several extension sets before they found one that didn¿t leak.

• Brand Name: 8.5 IN PRESSURE RATED MINIBORE SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12169458
• Report Number: 9616066-2021-51515
• Device Sequence Number: 19759084
• Product Code: FPA
• UDI-Device Identifier: 50885403236714
• UDI-Public: 50885403236714
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/14/2021

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: Health Professional
• Device Model Number: MP5313-C
• Device Catalogue Number: MP5313-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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