MAUDE Adverse Event Report: BAUSCH + LOMB MICROFLOW 2.2 NEEDLE; UNIT, PHACOFRAGMENTATION

Model Number	DP8730S
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has been requested for evaluation; however, it has not been received.Sterilization and lot history records were reviewed and no exceptions were found.Report 1 of 16.
Event or Problem Description
Fine metal dust/glittering particles were discovered within the incision.No patient impact or injury was reported.
Additional Manufacturer Narrative
Eighteen opened dp8730s pouches from lot v7941 were received in a cardboard box.A total of 18 needle tips were returned.Eight of the needle tips were lying loose in the cardboard box.All 18 were dirty with particulates and dried solutions visible all over.Microscopic examination found that the needles were damaged.The corners of the hub have marring, scratches and gouges with material missing.The damage to the hub is consistent with damage seen when the needle is over-tightened.There was also damage to the tips and scratches on the shafts of the needles.This could contribute to particulate generation during use.
Additional Manufacturer Narrative
Based on the results of our root cause investigation, it has been determined that the reported particulate is not related to any damage or malfunction of the product.Our investigation has concluded that the observed particles are originating from the metallic cap assembled to the needle wrench which when packaged in the same pouch with the silicone irrigation sleeve results in microscopic particles being transferred from the needle wrench cap to the irrigation sleeve.All products have been found to comply with specifications and function as intended.Additionally, there have been no reports of post-surgical adverse reaction.However, due to increased sightings of microscopic particles and our ongoing continuous improvement activities, we have taken measures to identify an internal cleaning process related to needle wrench assembly to address the reported events.Validation activities have been completed and the process has been implemented.In addition, we are reviewing our component specifications related to particulate matter and will revise specifications, where necessary, to better align with customer expectations.As a result of this additional information, it has been determined that the issue documented in this report does not meet the criteria of a reportable malfunction and the complaint record will be revised accordingly.

• Brand Name: MICROFLOW 2.2 NEEDLE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6373403
• Report Number: 0001920664-2017-00092
• Device Sequence Number: 442349
• Product Code: HQC
• UDI-Device Identifier: 10757770057259
• UDI-Public: (01)10757770057259(17)210820
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2017

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: 08/20/2021
• Device Model Number: DP8730S
• Device Lot Number: V7941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 04/11/2017; 06/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1