MAUDE Adverse Event Report: TELEFLEX MEDICAL ACE MEDICAL AF W/AS 550 X 1-14ML/HR CPNB; PUMP, INFUSION, ELASTOMERIC

Catalog Number	MVBXL-CPNB
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Complaint reported that: "pump was hooked up to the patient and while patient was still in recovery the line broke at the connection point and started to leak".No patient harm reported.No report of medical intervention.Patient condition reported as fine.
Additional Manufacturer Narrative
(b)(4).A device history record review was performed based upon a potential lot number from sales history data.A device history record review was performed with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based upon a potential lot number from sales history data.A device history record review was performed with no relevant findings.The potential cause of this complaint could not be determined based upon the information provided and without a sample.
Event or Problem Description
Complaint reported that: "pump was hooked up to the patient and while patient was still in recovery the line broke at the connection point and started to leak".No patient harm reported.No report of medical intervention.Patient condition reported as fine.

• Brand Name: ACE MEDICAL AF W/AS 550 X 1-14ML/HR CPNB
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15145197
• Report Number: 3004365956-2022-00048
• Device Sequence Number: 5234137
• Product Code: MEB
• UDI-Device Identifier: 24026704743548
• UDI-Public: 24026704743548
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K090300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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 Catalogue Number: MVBXL-CPNB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Male