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

Catalog Number SM0005-USA

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, no conclusion can be made.Preliminary evaluation of the sample finds a tear in the packaging confirming a sterile barrier breach.At this time the tear appears to be an outside in, tear.The sample has been sent to the manufacturing site for further review.A review of the manufacturing records was performed and found that the lot was manufactured to specification, with no anomalies noted.When the sample evaluation is completed, a supplemental mdr will be submitted.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 Description

As reported, upon opening the sterilized package of the bard/davol arista ah on (b)(6)2021, a tear was found on the white transparent film of the sterilized package.As reported, the arista ah package was fully sealed prior to opening and no damage was noted to the outer package.Customer reports sterile breach to the inner package is unknown.As reported, another device was used to complete the procedure.There was no reported patient injury.

Event Description

As reported, upon opening the sterilized package of the bard/davol arista ah on (b)(6) 2021, a tear was found on the white transparent film of the sterilized package.As reported, the arista ah package was fully sealed prior to opening and no damage was noted to the outer package.Customer reports sterile breach to the inner package is unknown.As reported, another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

At this time, no conclusion can be made.Preliminary evaluation of the sample finds a tear in the packaging confirming a sterile barrier breach.At this time the tear appears to be an outside in, tear.The sample has been sent to the manufacturing site for further review.A review of the manufacturing records was performed and found that the lot was manufactured to specification, with no anomalies noted.Addendum: h11: this is an addendum to the initial mdr, to document our investigation results.Based on the investigation performed, a tear in the tyvek and the foil pouch is confirmed resulting in a breach of the sterile barrier.Visual evaluation of the returned sample indicates an outside-in failure that is consistent with a foreign object penetrating into both inner/outer pouch.Manufacturing review found no anomalies.Retain samples had no defects.Exactly when the tear in the packaging occurred cannot be determined.Product in japan goes through a 100% inspection and over labeling per local requirements.If the problem was present at the time of processing it would have been noted as the damage was visible on the tyvek in the area above the label.Based on evaluation it appears the physical damaged presented in transit/handling after leaving bd control and prior to identification at the customer facility.To date, there have been no other complaints of this nature reported for this lot of (b)(4) units released for distribution in july 2019.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: ARISTA AH
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12545832
• MDR Text Key: 273760232
• Report Number: 1213643-2021-20343
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 00801741044113
• UDI-Public: (01)00801741044113
• Combination Product (y/n): N
• PMA/PMN Number: P050038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Catalogue Number: SM0005-USA
• Device Lot Number: 6134401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Initial Date Manufacturer Received: 09/04/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other