MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CENTER CUSTOM PAK; CONVENIENCE PAK

Model Number CUSTOM PAK

Device Problems Fluid/Blood Leak (1250); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

A nurse reported that during a pars plana vitrectomy and membranectomy with laser procedure, the trocar cannula was leaky and it was difficult to remove instruments without the trocar coming out with the instrument.The trocar was replaced with a standalone valved entry system, however the same issue occurred.Another standalone valved entry system was used to complete the case.There was no harm to the patient.No sample is available as the customer discarded the products.There are two related reports for this patient; this report is for the issue with the standalone valved entry system.

Manufacturer Narrative

No samples were returned for evaluation; therefore, the condition of the product could not be verified.The device history record (dhr) for the lots were reviewed.No abnormalities that could have contributed to the reported complaint were found during the dhr review and the product ws released according to the manufacturer's acceptance criteria.Because a sample was not returned and no evidence of nonconformity that could have caused the complaint could be found in the lot record review, the root cause for the customer complaint issue cannot be determined.(b)(4).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE PAK
• Manufacturer (Section D): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer (Section G): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3928691
• MDR Text Key: 4586860
• Report Number: 2028159-2014-01096
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2015
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Device Lot Number: 13031693X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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
• Treatment: TOTAL PLUS PAK, 25+ 5000 CUTS PER MINUTE; VALVE STD 25G VALVED ENTRY SYSTEM
• Patient Age: 90 YR