MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 OPTIFIX AT; STAPLE, IMPLANTABLE

Catalog Number	0113315
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	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march, 2020.When the investigation has been completed, a supplemental emdr will be submitted.
Event or Problem Description
As reported on (b)(6) 2020, when the surgeon opened the package of an optifix at there was a "hair-like" material noted inside the sterile package which looked like an eyelash prior to use on a patient.There was no reported patient injury but a short delay of few minutes while retrieving the new device.
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march, 2020.Addendum: this is an addendum to the initial mdr submitted to document the results of device evaluation.The returned sample was evaluated.Visual evaluation of the sample noted a small piece of black foreign material taped to the handle.Visual evaluation could not determine if the material is a hair or another type of foreign fiber.Initial evaluation finds the foreign material was present on the device handle when the unit was opened for use.Based on the investigation performed and sample evaluation, the foreign material most likely presented during the manufacturing process.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported on (b)(6) 2020, when the surgeon opened the package of an optifix at there was a "hair-like" material noted inside the sterile package which looked like an eyelash prior to use on a patient.There was no reported patient injury but a short delay of few minutes while retrieving the new device.

• Brand Name: OPTIFIX AT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10753926
• Report Number: 1213643-2020-20021
• Device Sequence Number: 16428592
• Product Code: GDW
• UDI-Device Identifier: 00801741136559
• UDI-Public: (01)00801741136559
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K191287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 0113315
• Device Lot Number: HUEP0700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other