MAUDE Adverse Event Report: ACCESS VASCULAR. INC. HYDROPICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	MID-251CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that the dual lumen picc line fractured during insertion on (b)(6) 2024.While flushing the catheter by hand, the user felt a "slight resistance" and then a "release".The catheter was removed and a break between the 11cm and 12cm markings was identified.The catheter was replaced with a new catheter.Avi requested that the catheter be returned for evaluation, but following three requests for the catheter's return, it was not returned and no additional information was provided.A review of lot history records did not identify any noncomformances with the lot.Based on the limited information provided, a root cause could not be determined.
Event or Problem Description
Customer reported a break in a dual lumen hydropicc.

• Brand Name: HYDROPICC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ACCESS VASCULAR. INC.; 749 middlesex turnpike; billerica MA 01821
• Manufacturer (Section G): ACCESS VASCULAR. INC.; 749 middlesex turnpike; billerica MA 01821
• Manufacturer Contact: brian hanley ; 749 middlesex turnpike; billerica 01821 ; 7815386594
• MDR Report Key: 20812291
• Report Number: 3015060232-2024-00027
• Device Sequence Number: 15821299
• Product Code: LJS
• UDI-Device Identifier: 00850030354334
• UDI-Public: (01)00850030354334
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K213550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/29/2024

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 Expiration Date: 02/28/2026
• Device Model Number: MID-251CM
• Device Catalogue Number: 80H02104
• Device Lot Number: 09202403
• 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: 10/05/2024
• Initial Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• 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
• Patient Sex: Unknown