MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C45101762

Device Problems Disconnection (1171); Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a portex® adult disposable anesthesia breathing circuit had a quality issue, which caused the circuit to disconnect intra-operatively.It was noted that patient safety was at risk due to the incident.It was additionally reported that there was a "mask disconnect from [the] elbow/circuit." no patient injury was reported.See mfr: 3012307300-2017-00031, 3012307300-2017-00032, 3012307300-2017-00033, 3012307300-2017-00034, 3012307300-2017-00070, 3012307300-2017-00071, 3012307300-2017-00072, 3012307300-2017-00073, 3012307300-2017-00074, 3012307300-2017-00075, 3012307300-2017-00076, 3012307300-2017-00077, 3012307300-2017-00078, 3012307300-2017-00079, 3012307300-2017-00080, 3012307300-2017-00081, 3012307300-2017-00082, 3012307300-2017-00083, 3012307300-2017-00084, 3012307300-2017-00085, 3012307300-2017-00086, 3012307300-2017-00087, 3012307300-2017-00088, 3012307300-2017-00089, 3012307300-2017-00090, 3012307300-2017-00091, 3012307300-2017-00092, 3012307300-2017-00093, 3012307300-2017-00094, 3012307300-2017-00095, 3012307300-2017-00096, 3012307300-2017-00097, 3012307300-2017-00098, 3012307300-2017-00099, 3012307300-2017-00100, 3012307300-2017-00101, 3012307300-2017-00102, 3012307300-2017-00103, 3012307300-2017-00104, 3012307300-2017-00105, 3012307300-2017-00106, 3012307300-2017-00107, 3012307300-2017-00108, 3012307300-2017-00109, 3012307300-2017-00110, 3012307300-2017-00111, 3012307300-2017-00112, 3012307300-2017-00113, 3012307300-2017-00114, 3012307300-2017-00115, 3012307300-2017-00116, 3012307300-2017-00117, 3012307300-2017-00118, 3012307300-2017-00119, 3012307300-2017-00120, 3012307300-2017-00121, 3012307300-2017-00122, 3012307300-2017-00123, 3012307300-2017-00124, 3012307300-2017-00125, 3012307300-2017-00126, 3012307300-2017-00127, 3012307300-2017-00128, 3012307300-2017-00129, 3012307300-2017-00130, 3012307300-2017-00131, 3012307300-2017-00132, 3012307300-2017-00133, 3012307300-2017-00134, 3012307300-2017-00135, 3012307300-2017-00136, 3012307300-2017-00137, 3012307300-2017-00138, 3012307300-2017-00139, 3012307300-2017-00140, 3012307300-2017-00141, 3012307300-2017-00142, 3012307300-2017-00143, 3012307300-2017-00144, 3012307300-2017-00145, 3012307300-2017-00146, 3012307300-2017-00147, 3012307300-2017-00148, 3012307300-2017-00149, 3012307300-2017-00150, 3012307300-2017-00151, 3012307300-2017-00152, 3012307300-2017-00153, 3012307300-2017-00154, 3012307300-2017-00155, 3012307300-2017-00156, 3012307300-2017-00157, 3012307300-2017-00158, 3012307300-2017-00159, 3012307300-2017-00160, 3012307300-2017-00161, 3012307300-2017-00162, 3012307300-2017-00163, 3012307300-2017-00164, and 3012307300-2017-00165.

• Brand Name: PORTEX® ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6219774
• MDR Text Key: 63799332
• Report Number: 3012307300-2017-00160
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C45101762
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1