MAUDE Adverse Event Report: TELEFLEX MEDICAL MULTI-ADAPTOR,15MM ID X 22MM OD; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number	1422
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual inspection of the product involved in the complaint was performed on the returned sample.It is noted that the product was not received in its original packaging.It can be observed a damage issue on the adaptor.No other issues were found.A device history record review showed that there were no issues related to the reported failure mode, neither on the product nor its components, during the manufacture of this material.Customer complaint is confirmed based on sample provided.However, there is not sufficient evidence to determine this issue originated during manufacturing process.The root cause for the condition reported could not be identified.No corrective actions can be assigned.The complaint is confirmed but the root cause could not be identified.Teleflex will continue to monitor and trend for reports of this issue.
Event or Problem Description
Customer complaint alleges they "are having issues with carefusion or teleflex products depositing shards of plastic in the circuits." alleged defect noted during use.No patient harm reported.

• Brand Name: MULTI-ADAPTOR,15MM ID X 22MM OD
• Common Device Name: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 6848514
• Report Number: 3004365956-2017-00337
• Device Sequence Number: 530866
• Product Code: BZA
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date (Section B): 08/17/2017

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: No Information
• Device Catalogue Number: 1422
• Device Lot Number: 74B1701012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CAREFUSION DEVICE