MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. AVITENE WEB SHEETS; AGENT, ABSORBABLE, HEMOSTATIC, COLLAGEN BASED

Catalog Number	1010250
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product has been received; however, due to the cv-19 closure impact of the evaluation lab, the evaluation of the physical sample has been delayed.A photo of the subject product was provided and confirms a thread resembling a ¿fiber¿ presented in the package with one end caught within the lid to tray package seal.The packaging of the subject product in the provided photo appears to be in an unopened state.Although the quality of the photo is limited, it appears that the fiber does not impact the entire width of the package seal.Based on the review of the provided photo, the source of the unidentified fiber appears to be manufacturing related; however, until the evaluation of the sample can be performed, the identification, possible origin of the fiber, and impact on seal cannot be determined.When the sample has been evaluated, a supplemental mdr will be submitted.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This is the first report of foreign material for the subject lot of 6000 units manufactured in january of 2019.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.Sample not available for evaluation at this time.
Event or Problem Description
It was reported that a fiber was caught between the tyvek lid and tray of the avitene product.Another avitene product was used to complete the case.There was no patient involvement reported.
Additional Manufacturer Narrative
The subject product has been received; however, due to the cv-19 closure impact of the evaluation lab, the evaluation of the physical sample has been delayed.A photo of the subject product was provided and confirms a thread resembling a ¿fiber¿ presented in the package with one end caught within the lid to tray package seal.The packaging of the subject product in the provided photo appears to be in an unopened state.Although the quality of the photo is limited, it appears that the fiber does not impact the entire width of the package seal.Based on the review of the provided photo, the source of the unidentified fiber appears to be manufacturing related; however, until the evaluation of the sample can be performed, the identification, possible origin of the fiber, and impact on seal cannot be determined.When the sample has been evaluated, a supplemental mdr will be submitted.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This is the first report of foreign material for the subject lot of (b)(4) units manufactured in january of 2019.This is an addendum to the initial emdr to document the sample evaluation.The sample evaluation confirms there is a hair under the tyvek seal of the inner tray containing the device.The hair was caught in the seal and can been seen within the product tray confirming this to be a manufacturing related incident.The inner tray holding the product is not designed to be the sterile barrier.The product outer foil pouch is the sterile barrier.No damage is identified to the outer foil pouch.As such no breach of sterility is found.Additionally, analytical testing performed confirms the fiber found within the product packaging to be shed human hair.Awareness training was performed with the manufacturing operators.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
It was reported that a fiber was caught between the tyvek lid and tray of the avitene product.Another avitene product was used to complete the case.There was no patient involvement reported.

• Brand Name: AVITENE WEB SHEETS
• Common Device Name: AGENT, ABSORBABLE, HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10004879
• Report Number: 1213643-2020-04114
• Device Sequence Number: 11487235
• Product Code: LMF
• UDI-Device Identifier: 00801741010460
• UDI-Public: (01)00801741010460
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P800002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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: 12/28/2022
• Device Catalogue Number: 1010250
• Device Lot Number: WBCZ0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1