MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC AMO ADMINISTRATION SET; DEVICE, IRRIGATION, OCULAR SURGERY

Model Number	OM2505191
Medical Device Problem Codes	Misassembled (1398); Delivered as Unsterile Product (1421); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : see h10.
Event or Problem Description
It was reported that several iv admin sets had loose/missing tips on the leur-lock end and customer was unable to use them due to sterility.Through follow up customer confirmed that there was a breach in the sterile barrier.Some were noted upon opening the product and a couple were noticed before opening, while looking at the packaging.No additional information was provided.This report is 3 of 4 reported.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes, returned to manufacturer on 07/23/2024.Section h3: device evaluated by manufacturer: yes.After further investigation it was identified the blister packaging with the tyvek is the sterile barrier and not the vented caps on the set.The caps coming off in stage of the process would not impact the sterility of the package contents since the part is not a sterile fluid path.There is no indication of a breach in sterility; therefore, this event is no longer reportable.Regarding the cap not attached to the male luer-lock, this issue was investigated and is not related to a sterility issue.It was identified that the most probable cause for the cap not attached to the male luer-lock was insufficient tightening of the caps on the male luer-lock adapter.An awareness was conducted to all personnel involved in manufacturing of the reported complaint product to reinforce the visual inspection during the manufacturing process, to prevent recurrence.All pertinent information available to johnson & johnson surgical vision, inc.Has been provided.

• Brand Name: AMO ADMINISTRATION SET
• Common Device Name: DEVICE, IRRIGATION, OCULAR SURGERY
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18610823
• Report Number: 3012236936-2024-00244
• Device Sequence Number: 7509273
• Product Code: KYG
• UDI-Device Identifier: 15050474520698
• UDI-Public: (01)15050474520698(17)260430(10)0061884824
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K981116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: OM2505191
• Device Catalogue Number: OM2505191
• Device Lot Number: 0061884824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown