MAUDE Adverse Event Report: BD 9 IN EXTENSION SET W/MAX Y; INTRAVASCULAR ADMINISTRATION SET

Model Number	MPX5300-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one sample was received for quality investigation.The customer complaint of separation was verified by visual inspection.The sample submitted was evaluated and it was determined that only a partial sample was received.The tubing distal to the smartsite, and male luer connection, were not submitted with the sample.A closer inspection, under magnification, shows that there is a lack of solvent the union location.A device history record review for model mpx5300-c lot number 21055408 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 06may2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of the issue seen in this complaint is a lack solvent at the union location.The lack of solvent made it possible for the tubing to separate from the assembly with minimal amount of force applied.This incident has been added to our database of reported incidents.
Event or Problem Description
It was reported when using the bd 9 in extension set w/max y, the device experienced component separation, and leakage.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that the extension set separated at the midway junction which resulted in free flow blood to leave the patient.This also resulted in the primary tubing to allow medication onto the linen.Update (b)(6) 2021: peripheral iv extension found in 2 parts.These 2 pieces separated at the mid way junction.One half was connected to the patient allowing free flowing blood to leave the patient.The other half was connected to the primary iv tubing thus allowing iv medication to flow onto the linen.

• Brand Name: BD 9 IN EXTENSION SET W/MAX Y
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12547106
• Report Number: 9616066-2021-52136
• Device Sequence Number: 20127227
• Product Code: FPA
• UDI-Device Identifier: 50885403237216
• UDI-Public: 50885403237216
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 09/07/2021

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: MPX5300-C
• Device Catalogue Number: MPX5300-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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