MAUDE Adverse Event Report: ARROW MEDSOURCE GROUP LIMITED TUBING, SUCTION, CONNECTOR, 1/4" X 6' (6 MM X 1.8 M); TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Model Number	71-C606
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported that the 6mm tubing was observed having difficult with securement of items within the "grip" of the connector persisted on all of the tubing skus in their inventory.Deroyal industries requested the return of the device but it has not yet been received.A supplier corrective action request (scar) has been issued to the supplier.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information is available.
Event or Problem Description
A user facility reported that the 6mm tubing was observed having difficult with securement of items within the "grip" of the connector persisted on all of the tubing skus in their inventory.
Additional Manufacturer Narrative
A user facility reported that the 6mm tubing was observed having difficult with securement of items within the "grip" of the connector persisted on all of the tubing skus in their inventory.Deroyal industries performed an inventory check on one case that was found in inventory of the tubing.All products were found to be acceptable with no issues found.No failure modes and effects analysis could be reviewed by deroyal as this is a purchased product.Deroyal did review corrective and preventive actions but none were related to this product.Deroyal ran a complaint to sales ratio for this product from february 2023 to february 2025 and found it to be (b)(4).The scar was returned after the supplier completed their investigation.The supplier checked for existing inventory, but none was available in the factory.A total of 8 samples were inspected in previous batches and all were found to be within the specification range.Root cause: because no specific issues were found within the investigation, no root cause could be determined.Potential root cause: while it could not be confirmed, there is a potential that the inner diameter of the joint is too large to fit the suction head.Corrective and preventive actions: while no root cause was specifically determined, there is a modification to the internal dimensions of the joint being made.Deroyal will continue to monitor for trends around this item and issue.The investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: TUBING, SUCTION, CONNECTOR, 1/4" X 6' (6 MM X 1.8 M)
• Common Device Name: TUBE, ASPIRATING, FLEXIBLE, CONNECTING
• Manufacturer (Section D): ARROW MEDSOURCE GROUP LIMITED; unit 1104, yueda 889 center; 1111 changshou rd, jingan; shanghai, ; CH
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 21327163
• Report Number: 1060680-2025-00012
• Device Sequence Number: 12741267
• Product Code: BYY
• UDI-Device Identifier: 00749756579117
• UDI-Public: 00749756579117
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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 Model Number: 71-C606
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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