MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 48IN (121.9CM) INJ LINE ROTATING ADAPT (900PSI) 25/CA; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MX694R
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the rotating adapter was unsealed and contrast leaked out during injection.The rotating adapter had been previously checked and determined tight.The patient required immediate replacement to be able to continue operations.There was patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
D9.Date returned to mfg: 01-oct-2024 investigation summary: received one (1) used sample for evaluation.As received the rotator was observed to be separated from the tubing.Inspection of the tubing and rotator bond pocket showed evidence of solvent application.The complaint for unsealed rotating adaptor and subsequent leakage can be confirmed due to the separation observed between the tube and the rotator.The probable cause is unknown.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: 48IN (121.9CM) INJ LINE ROTATING ADAPT (900PSI) 25/CA
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20240230
• Report Number: 9616567-2024-00124
• Device Sequence Number: 20873743
• Product Code: FPA
• UDI-Device Identifier: 10351688505798
• UDI-Public: (01)10351688505798(17)270408(10)6008130
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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 Catalogue Number: MX694R
• Device Lot Number: 6008130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 12/05/2024
• 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
• Patient Sex: Unknown