MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number 16470

Device Problems Detachment Of Device Component (1104); Material Puncture/Hole (1504); Device-Device Incompatibility (2919)

Patient Problem No Information (3190)

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that the cannula came off the syringe during a procedure and punctured capsular bag.Additional information will be requested.

Manufacturer Narrative

The finished good lot specific to this event is not known; therefore, lot history and device history record review was not possible.A sample was not returned for this complaint.When this type of issue occurs, a sample will need to be returned so that a proper investigation can be conducted.If a sample is returned at a later date, the investigation will be reopened and the sample evaluated.Manufacturer does not attach third party cannulas to syringes.The root cause of the customer's complaint could not be established.Without a sample or description of the complaint, it is not possible to isolate the root cause.Possible root causes include an error in the supplier¿s manufacturing process or user mishandling.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.Action will not be taken for this occurrence since there is no sample or photo to send to the vendor.Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary.(b)(4).

• Brand Name: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7393018
• MDR Text Key: 104198322
• Report Number: 1644019-2018-00091
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16470
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other