MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; DBD-CATARACT PACK

Model Number DYNJ44929C

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that on (b)(6) 2020 during a cataract procedure, upon injection using a 3 ml syringe (a component of medline cataract pack (dynj44929c) flecks of debris, and sediment was injected into the patient's eye.The reporter states, "the debris was successfully irrigated out of the eye and per routine antibiotics were given." the reporter states, "no injury was detected, no change in routine post-op care was indicated.The reporter states, "patient is doing beautifully." sample has not been returned for evaluation.No further information is available at this time.Due to the nature of the reported incident and medical intervention provided this medwatch is being filed.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that during a cataract procedure, upon injection flecks of debris and sediment was injected into the patient's eye.

Manufacturer Narrative

A sample was received for our investigation.We received one full, unopened pack for our investigation.We examined each item within the pack for the reported debris.We also examined the tray containing the cotton tip applicators and the syringes under magnification.We were unable to identify particulate (foreign or component related) on any of the items in the pack.Reviewed the work order and there were no non-conformances related to the reported issue.Reviewed the pack build history and the syringes are placed into a poly bag inside the tray.Inside the tray is instrument wipes within reclosable bags, steri drape, eye spears within packaging, eye pads within the vendor packaging, labels, markers and needles.There are loose cotton tip applicators within a tray in the last fold of the pack which is not recommended, however they are not in contact with the area of the pack containing the syringes so transfer there is unlikely.Trending: trending was reviewed and there have been 1 additional reported complaint(s) for this issue in the past 6 months.Investigation summary: the account reported finding flecks of white debris/sediment in eyes.The reported issue occurred in item dynj44929c (lot 20bdb783).With the sample provided we are unable to confirm the reported issue and determine a root cause as the particulate and the original source cannot be identified.This complaint was closed with cause code: zcd00006/unconfirmed defect; 0002/not confirmed with received sample.

Event Description

It was reported that during a cataract procedure, upon injection flecks of debris and sediment was injected into the patient's eye.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: DBD-CATARACT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10454897
• MDR Text Key: 209211375
• Report Number: 1423395-2020-00021
• Device Sequence Number: 1
• Product Code: OJK
• UDI-Device Identifier: 10889942601752
• UDI-Public: 10889942601752
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

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 Model Number: DYNJ44929C
• Device Catalogue Number: DYNJ44929C
• Device Lot Number: 20BDB783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention