MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. PACK, COMPACT INTUITIV, MULTIPLE-USE; TUBING PACK

Model Number OPO85

Device Problems Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.

Event Description

Customer reported they received a shipment of opo85 compact intuitive multiple-use tubing packs, and one of them was damaged and would not be considered sterile for patient use.

Manufacturer Narrative

Correction: d9 returned to manufacturer - no.It was initially reported that the device was returned to the manufacturer however, the device was not.No physical product was received and only pictures were provided.Additional information: d9 - device available for evaluation? yes.H3 - device evaluated by manufacturer? yes.H6 type of investigation codes - 4114, 4112, 4120, 3331, 4110 and 4109.H6 investigation findings - code 171.H6 conclusion codes - 4315.Evaluation: a review of the records related to this equipment that included labeling, manual, trending, and risk documentation reviews for this equipment were performed.All devices meet material, assembly, and performance specifications at the time of product release.No physical product has been received but an image of the suspect product was provided by the complainant.The image displays 1 opo85 tubing pack from the reported lot 60254073 with the seal of the tyvek lid still seemingly intact and unopened.A puncture/hole is visible near the center of the tyvek lid.The reported issue is confirmed through the provided photo, however without a product return how and when the damage was introduced cannot be determined.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: section h6: as part of an internal review of our mdrs it was identified that the code 2975 was not added to the initial report.Section h6: component code added: 4755 and 4747.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: PACK, COMPACT INTUITIV, MULTIPLE-USE
• Type of Device: TUBING PACK
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer Contact: somyata nagpal ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11952855
• MDR Text Key: 263212972
• Report Number: 2020664-2021-07042
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 35050474573360
• UDI-Public: (01)35050474573360(17)230813(10)60254073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2023
• Device Model Number: OPO85
• Device Lot Number: 60254073
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 08/17/2021; 10/20/2022
• Supplement Dates FDA Received: 09/03/2021; 10/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1