MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO PERFORMA NON-BRAIDED PEDIATRIC PIGTAIL CATHETER; PERFORMA NON-BRAIDED CATHETER

Catalog Number	7757-2MP65SH/B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The customer alleges the catheter came apart at the hub during procedure patient physician noticed patient was losing blood and second catheter was opened.The case went fine.Post procedure, the physician was testing the catheter again and the same thing happened.The patient received 30cc of blood.The patient was transferred back to nicu in good condition.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: PERFORMA NON-BRAIDED PEDIATRIC PIGTAIL CATHETER
• Common Device Name: PERFORMA NON-BRAIDED CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton bsn, rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 20001907
• Report Number: 3011642792-2024-00053
• Device Sequence Number: 4929553
• Product Code: DQO
• UDI-Device Identifier: 00884450766514
• UDI-Public: 00884450766514
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7757-2MP65SH/B
• Device Lot Number: I2900540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown