MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 AVITENE ULTRAFOAM; AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED

Catalog Number	1050040
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a short black hair was found in avitene ultrafoam.Visual inspection of the returned sample finds a foreign hair like material black in color on the product within the opened sterile pouch.It does not appear the hair presents into the material itself and is found to be laying on the product.Evaluation and root cause investigation is still ongoing.When the investigation is completed, a supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 1610 units released for distribution in april 2023.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, during a procedure, the surgical tech on the sterile field cut into the avitene ultrafoam and a short black hair emerged from the inside of the foam.There was no reported patient injury.
Event or Problem Description
As reported, during a procedure, the surgical tech on the sterile field cut into the avitene ultrafoam and a short black hair emerged from the inside of the foam.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, a short black hair was found in avitene ultrafoam.Visual inspection of the returned sample finds a foreign hair like material black in color on the product within the opened sterile pouch.It does not appear the hair presents into the material itself and is found to be laying on the product.Evaluation and root cause investigation is still ongoing.When the investigation is completed, a supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 1610 units released for distribution in april 2023.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Visual inspection of the unit received finds a foreign hair like material black in color on the product within the opened sterile pouch.It does not appear the hair presents into the material itself and is found to be laying on the product.The hair has the features of a human hair.Based on the investigation performed the confirmed hair likely presented during the manufacturing process.An awareness training was performed to the operators on gowning and other manufacturing related processes deemed necessary.Updated fields: b4, g3, g6, h2, h3, h6, h10.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.H3 other text : sample evaluated.

• Brand Name: AVITENE ULTRAFOAM
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL INC. -1223089; 160 new boston st.; woburn MA 01801
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 17690637
• Report Number: 1213643-2023-00320
• Device Sequence Number: 12394945
• Product Code: LMF
• UDI-Device Identifier: 00801741010545
• UDI-Public: (01)00801741010545
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: N17600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: 04/28/2026
• Device Catalogue Number: 1050040
• Device Lot Number: WBHQ0041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown