MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY 1/4IN (6.4MM) X 6 (1.8M) (50/CS); TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Model Number	0036280
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event is confirmed.Customer event ¿insufficient heatseal¿ was confirmed based on photographic evidence and device evaluation.Two 0036280 returned unopened in original packaging.The lot number of the device ¿ 202002215 was verified.A visual inspection found a hole in the packaging of one device.The packaging of the second device was lifting creating a gap in the seal.A functional test was performed on the device without an obvious breach which indicated an insufficient heat seal.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: sterility is guaranteed unless package has been opened, broken, or damaged.This issue will continue to be monitored through the complaint system to assure patient safety.Note:.
Event or Problem Description
During incoming inspection, the distributor rejected this device, 0036280, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 1/4IN (6.4MM) X 6 (1.8M) (50/CS)
• Common Device Name: TUBE, ASPIRATING, FLEXIBLE, CONNECTING
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 12408482
• Report Number: 3007305485-2021-00361
• Device Sequence Number: 4181360
• Product Code: BYY
• UDI-Device Identifier: 10653405000464
• UDI-Public: (01)10653405000464(17)250219(10)202002215
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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: Other
• Device Expiration Date: 02/19/2025
• Device Model Number: 0036280
• Device Catalogue Number: 0036280
• Device Lot Number: 202002215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1