MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS SIGNATURE PACK, DISPOSABLE TUBING; PHACO TUBING

Model Number OPO71

Device Problems Device Emits Odor (1425); Device Contamination With Biological Material (2908)

Patient Problem No Patient Involvement (2645)

Event Date 04/28/2015

Event Type  malfunction  

Manufacturer Narrative

There are 2 possible causes that could not be eliminated related to the shipment conditioning from the manufacturing facility until reaching the customer and the storage condition at the customer site.For one related to product shipment, there is no evidence found in existing documentation that evidence some related adverse condition that could have been linked to the evidence.All pertinent information available to abbott medical optics has been submitted.

Event Description

A surgery center reported upon opening a tubing pack, there was an orange fluffy substance on the tubing pack.The surgeon indicated observing an orange powder having an odor upon opening the tubing pack.There was no patient involvement.As a precaution, the surgery center striped the entire room.

Manufacturer Narrative

Expiration date 1/2017.The tubing pack, tray, and lid were returned to abbott medical optics for evaluation.The manufacturing record review was performed.There were no issues noted during the manufacturing process.There were no deviations from standard procedure.The clean-room monitoring results were that a trend evaluation for air microbes, air particles, and work station microbes showed no abnormal condition in the clean-rooms.No information to suggest a device quality deficiency related to this event.Historically, there is no adverse trend for the suspected model with the designated complaint type.Follow up on the storage conditions of the location site was made.The customer indicated the tubing packs are stored in 2 locations.One in the basement, where the storage temperatures are controlled due to a research department operates in the basement.The 2nd location is stored in a small room on the level of the hospital.The temperature is controlled however, when an amo representative visited the site, a small refrigerator was next to the tubing packs.It is unknown if the contents of the refrigerator may have contributed to the fungus/mold found on the tubing pack.In addition, a third party performed analysis of a swab containing the orange fluffy substance by fourier transform infrared spectroscopy(ftir), scanning electron microscopy(sem) and energy dispersive x-ray spectroscopy(edx) in order to characterize the foreign material.Visual examination revealed a white to yellow to orange colored fuzzy cluster.The ftir, sem, and edx data for the orange fluffy substance is consistent with a biological (fungus/mold) material.Abbott medical optics performed a microbiology testing.Sub-culturing occurred bench-top on two different dates (b)(6) 2015.The samples were taken from the inner tyvek lid, tray, and bag.When sub-culturing, filamentous hyphae were seen on the inner side of the tyvek lid and orange powder from the mold spores was observed on the bag and tubing area underneath the tyvek lid.All plates exhibited similar growth.Although both dates from the sub-culturing revealed similar growth and the same filamentous hyphae, there was a black/brown mold observed on the last test date, the fact that the dark color (brown/black) mold may be an environmental contaminant not related to the original complaint event as received from the customer as it may not represent the condition of the product when received at abbott medical optics.One of the plates sub-cultured was sent to for microorganism identification.The test results identified the contaminant as neurospora sitophila/tetrasperma.Manufacturer date 1/2015.Additional method codes: (b)(4).All pertinent information available to abbott medical optics has been submitted.Placeholder.

• Brand Name: SIGNATURE PACK, DISPOSABLE TUBING
• Type of Device: PHACO TUBING
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: lourdes guevara ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478497
• MDR Report Key: 4800485
• MDR Text Key: 18476640
• Report Number: 2648035-2015-00322
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPO71
• Device Lot Number: CA00052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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