MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 ARISTA AH ABSORBABLE HEMOSTAT; AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED

Model Number	SM0005-USA
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	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.However, a photo was provided.This is a double pouch single use device.The photo shows the outer layer of packaging has been opened and there is what appears to be a hair laying on top of the inner package.The inner package has not been opened.The hair is not within the inner most package and would have no effect on the product.Review of the photo confirms the presence of what appears to be a hair on the package, however does not assist in determining a root cause for the presence of this foreign material as the outer package had been opened at point of use.To date there have been no other reported complaints for this lot.Not returned.
Event or Problem Description
As reported, on (b)(6) 2021 during a procedure, a hair was found inside the sterile packaging of arista ah.There was no impact to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.However, a photo was provided.This is a double pouch single use device.The photo shows the outer layer of packaging has been opened and there is what appears to be a hair laying on top of the inner package.The inner package has not been opened.The hair is not within the inner most package and would have no effect on the product.Review of the photo confirms the presence of what appears to be a hair on the package, however does not assist in determining a root cause for the presence of this foreign material as the outer package had been opened at point of use.To date there have been no other reported complaints for this lot.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of re-review of the photo provided.As the photo shows what appears to be a hair laying on the foil pouch which is within the sterile tyvek pouch, root cause is most reasonable determined to be manufacturing related.Review of manufacturing records shows product was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of 3975 units released for distribution in july, 2021.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) 2021 during a procedure, a hair was found inside the sterile packaging of arista ah.There was no impact to the patient.

• Brand Name: ARISTA AH ABSORBABLE HEMOSTAT
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON 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: 12751518
• Report Number: 1213643-2021-20393
• Device Sequence Number: 1454797
• Product Code: LMG
• UDI-Device Identifier: 00801741044120
• UDI-Public: (01)00801741044120
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050038
• 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): 11/29/2021

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: 04/28/2025
• Device Model Number: SM0005-USA
• Device Catalogue Number: SM0005-USA
• Device Lot Number: WBET0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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