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

Catalog Number	0113330
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, upon opening a case box of bard/davol optifix at on (b)(6) 2022, one of the unit¿s exterior boxes was noted damaged and the internal sterile package was damaged as well.As reported, a small pin hole like damage was noted in that packaging.There was no reported patient involvement.
Additional Manufacturer Narrative
The subject device was returned for evaluation.Visual evaluation of the subject device returned, and the photo provided confirmed that the product carton is damaged.The product carton is torn and crushed in the corner which has exposed the inner sterile foil pouch.Damage to the product carton is the result of an outside force pushing the corner inward.Testing was performed on the sterile foil pouch and found that there was no pinhole present in the foil pouch as reported.The damage to the product carton resulted in creasing and dents presenting in the foil pouch.Based on the sample evaluation and investigation performed, the reported event of a sterile barrier breach was unconfirmed.The product is found to have been damaged in transit.Review of manufacturing records was performed with no anomalies noted and with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february 2022.Sample evaluated.
Event or Problem Description
As reported, upon opening a case box of bard/davol optifix at on (b)(6) 2022, one of the unit¿s exterior boxes was noted damaged and the internal sterile package was damaged as well.As reported, a small pin hole like damage was noted in that packaging.There was no reported patient involvement.
Additional Manufacturer Narrative
The subject device was returned for evaluation.Visual evaluation of the subject device returned, and the photo provided confirmed that the product carton is damaged.The product carton is torn and crushed in the corner which has exposed the inner sterile foil pouch.Damage to the product carton is the result of an outside force pushing the corner inward.Testing was performed on the sterile foil pouch and found that there was no pinhole present in the foil pouch as reported.The damage to the product carton resulted in creasing and dents presenting in the foil pouch.Based on the sample evaluation and investigation performed, the reported event of a sterile barrier breach was unconfirmed.The product is found to have been damaged in transit.Review of manufacturing records was performed with no anomalies noted and with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february 2022.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental emdr is submitted to correct the imdrf annex g component code.Corrected field: h6 (imdrf annex g component code).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: OPTIFIX AT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 14568467
• Report Number: 1213643-2022-00369
• Device Sequence Number: 5082537
• Product Code: GDW
• UDI-Device Identifier: 00801741136566
• UDI-Public: (01)00801741136566
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K191287
• 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): 06/06/2022

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: 11/28/2023
• Device Catalogue Number: 0113330
• Device Lot Number: HUFZ1051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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