MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY 1/4 IN ID X 12 FT L (.64CM IDX3.7M L) (20/CS); TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Model Number	0036550
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
Customer event ¿insufficient heat-seal¿ was confirmed based on photographic evidence and device evaluation.One 0036550 returned unopened in original packaging.The lot number of the device 202001064 was verified.A visual inspection found the heat seal was sealed inconsistently with folds found along the seal.A part of the seal was lifting with the clear side of packaging and paper side separating.A small open hole was found along the seal where a part of the clear side of the packaging had separated from the paper.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.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
During incoming inspection, the distributor rejected this device, 0036550, for an insufficient heat-seal.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: 1/4 IN ID X 12 FT L (.64CM IDX3.7M L) (20/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: 12370404
• Report Number: 3007305485-2021-00349
• Device Sequence Number: 14536470
• Product Code: BYY
• UDI-Device Identifier: 10653405000525
• UDI-Public: (01)10653405000525(17)250104(10)202001064
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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: 01/04/2025
• Device Model Number: 0036550
• Device Catalogue Number: 0036550
• Device Lot Number: 202001064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1