MAUDE Adverse Event Report: MPS PHARMA & MEDICAL, INC. MEDROPPER OPHTHALMIC DROPPER BOTTLE; 7 ML STERILE EYE DROPPER BOTTLE

Model Number AC211632-12

Device Problems Contamination (1120); Material Discolored (1170); Device Contaminated at the User Facility (4064)

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

Event Date 05/05/2023

Event Type  malfunction  

Event Description

A compounding pharmacy filed a voluntary medwatch malfunction report with fda, reference #mw5117467 which stated "inspecting product from mps pharma & medical cat.No: ac211632-12, lot m68406, a spec was noticed inside the 7ml dropper bottle.Spec was placed on a slide and reviewed, speck is a thrip (an insect).Several more bottles have been found with this in them.These are sterile packaged items with this insect in them." the device is an empty, clear, pre-assembled, sterile, 7 ml eye dropper bottle.There was no patient involvement, and the issue was identified at the compounding pharmacy.The bottle with the insect was not returned to the manufacturer for inspection or analysis, only a photo of the insect was provided.The unopened packages with the "speck" were returned to the manufacturer and evaluated.The findings revealed no insects in any of the other sealed packages.The customer was informed of the investigation findings.Compounded drugs are exempt from gmps, and testing to assess product quality is inconsistent.Compounding drugs in the absence of gmps increases the potential for preparation errors.Compounded sterile preparations pose the additional risk of microbial contamination to patients.[gudeman j, jozwiakowski m, chollet j, randell m.Potential risks of pharmacy compounding.Drugs r d.2013;13:1-8.].This is the first complaint of this type.Given the nature of the compounding process, the inherent potential for introduction of contaminants, and the exhaustive inspection of other devices from this lot, the reported issue cannot be confirmed and source of the alleged insect remains in question.

Manufacturer Narrative

The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.The 7 ml bottle with the insect was not returned to the manufacturer for inspection or analysis.The customer supplied 2 photographs.One microscopic image shows the insect on a slide.The second image shows a sealed package with a dark speck on the bottle inside circled in black ink.This device sample was sent out to an independent third-party laboratory for ftir analysis and was not identified as an insect, but was identified as polyethylene.In addition, the customer requested that their remaining unopened units from this lot be returned to the manufacturer.All returned samples (66 sealed pouches containing a total of 792 dropper bottles) were from the same manufacturing lot as the suspect lot.The devices were inspected for insects or loose foreign particulates inside the bottle and none were found (0/792, 0.0%).Magnified visual inspection of the 792 bottles in their sealed packaging identified that a very small percentage (4/192, 0.5%) had small dark specks embedded within the bottle (i.E., not loose and have no potential to detach and be delivered into the eye).In all cases, the dark specks represent an inherent cosmetic defect from the molding process and the speck size was less than the acceptable criteria of < 0.4 mm².Two device samples were sent to an approved third-party laboratory for ftir analysis.One sample was the returned device in question (the package with the speck circled in black ink) and the second sample was a random sample from this same lot that was used as the reference material.The ftir analysis test report from the third-party laboratory conclusively identified the embedded dark-colored speck as polyethylene (which is the bottle material) and ruled out any material that could be indicative of insect origin.The dark colored speck was the result of an acceptable cosmetic defect from the molding process.No insects or loose foreign particulates were found in any of the dropper bottle samples tested or examined.In an abundance of caution, all of the entire remaining inventory of this device model (21,816 bottles) within the manufacturer's control was subjected to 100% magnified visual inspection of the sealed bottles and packaging.No insects or loose foreign particulates were found in any of the bottles or sterile packaging.A complaint history record review was conducted and the complaint records for the past 9 years (2014 to 2023) were reviewed.There have been no other complaints of insects inside the bottles or packaging of with any medical device manufactured by mps pharma.Great quantities of dropper bottles and bottle tips have been distributed throughout the u.S.And canada.No other complaints related to insects inside the bottles or packaging were reported.Mps bottles are manufactured in a controlled environment and packaged in a clean room class 7.The mps pharma manufacturing facility is monitored per environmental control requirements.Bottle parts are inspected at every stage to ensure no loose particulates of any kind are present.Dropper bottles are sent to an approved third-party laboratory for usp 788 testing using method 1.Results from usp 788 for this lot and 15 other lot numbers passed usp 788 method 1.In summary, usp test results indicate there is no cause for concern with regard to the presence of loose particulates or insects.This alleged complaint represents an isolated incident with a reported occurrence of 0.0004%, which is improbable.During the compounding process, there are several other components and factors upstream from bottle filling that carry the potential to introduce contaminants.The mps bottle is the final filling reservoir that catches potential contaminants from all these potential sources.Based on the information, documentation, and extensive samples inspected in this robust investigation, it was concluded there is insufficient evidence to determine how and when the insect was introduced into the bottle.Compounding pharmacies standard practice is to ensure that all compounded drug products are 100% visually inspected for visible defects prior to labeling and final release of drug products.Mps pharma supplies empty bottles to compounding pharmacies throughout the u.S.And canada.Given the large quantity of devices distributed and absence of any other similar reports during their final 100% inspections; we therefore conclude it is improbable that the bottle supplied to the customer contained the insect at final product release.While we cannot conclusively confirm that the insect found by the customer was present in the bottle prior to compounding, independent ftir analysis demonstrated that the alleged additional "insects" identified by the customer as being inside the sealed packages were not insects, but were identified as a known and acceptable cosmetic defect common in the injection molding processes (i.E., the devices met specifications).Based on the robust and exhaustive investigation the alleged complaint cannot be confirmed and there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing or quality control.Manufacturer's reference #: (b)(4).Voluntary medwatch reference #: mw5117467.

• Brand Name: MEDROPPER OPHTHALMIC DROPPER BOTTLE
• Type of Device: 7 ML STERILE EYE DROPPER BOTTLE
• Manufacturer (Section D): MPS PHARMA & MEDICAL, INC.; 465 n. berry street; brea CA 92821
• Manufacturer (Section G): MPS PHARMA & MEDICAL, INC.; 465 n. berry street; brea CA 92821
• Manufacturer Contact: jordan kazemi ; 465 n. berry street; brea, CA 92821 ; 8446413814
• MDR Report Key: 17599564
• MDR Text Key: 321722806
• Report Number: 3018125942-2023-00001
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AC211632-12
• Device Lot Number: M68406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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