MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 KUGEL PATCH; SURGICAL MESH

Catalog Number 0010101

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/15/2021

Event Type  malfunction  

Event Description

As reported, a small "ant-like insect" was noted near the center of the bard/davol kugel patch immediately after opening the sterilized package on (b)(6) 2021.As reported, that a second kugel patch was used to complete procedure.There was no reported patient injury.

Manufacturer Narrative

At this time no conclusion can be made.Photos were provided depicting the product carton and the opened inner sterile pouch which contains the kugel patch.Seen in the photo showing the mesh in the opened pouch is a small foreign material in the center of the mesh as reported.The foreign material appears black in color.Review of the photo can confirm the presence of a foreign material on the mesh in the opened pouch.Identification of the type or source of the material cannot be determined at this time.It is reported that the subject device is being returned for evaluation, however has not yet been received.If/when the sample is received and evaluated a supplemental emdr will be submitted.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in april, 2020.

Manufacturer Narrative

At this time no conclusion can be made.Photos were provided depicting the product carton and the opened inner sterile pouch which contains the kugel patch.Seen in the photo showing the mesh in the opened pouch is a small foreign material in the center of the mesh as reported.The foreign material appears black in color.Review of the photo can confirm the presence of a foreign material on the mesh in the opened pouch.Identification of the type or source of the material cannot be determined at this time.It is reported that the subject device is being returned for evaluation, however has not yet been received.If/when the sample is received and evaluated a supplemental emdr will be submitted.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of 236 units released for distribution in april, 2020.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the result of sample evaluation.Initial evaluation of the sample finds the sample to be unused as expected.The tyvek pouch had been opened by the user.The foreign material seen in the photo provided was found to be loose within the tyvek pouch and is no longer on the mesh.The foreign material found in the tyvek pouch matches that depicted in the photo and it appears to be fiber like and black in color and is not an insect as reported.Based on the sample evaluation, the reported event is confirmed, however as the package was opened by the user it cannot be determined when/where the material was introduced into the package, as such root cause is unknown.It can be confirmed that the black fiber like foreign material observed is not related to the manufacturing process.Updated fields: b4, d9, 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.

Event Description

As reported, a small "ant-like insect" was noted near the center of the bard/davol kugel patch immediately after opening the sterilized package on (b)(6) 2021.As reported, that a second kugel patch was used to complete procedure.There was no reported patient injury.

• Brand Name: KUGEL PATCH
• Type of Device: SURGICAL MESH
• 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: 12782839
• MDR Text Key: 282099245
• Report Number: 1213643-2021-20397
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016332
• UDI-Public: (01)00801741016332
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K963141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0010101
• Device Lot Number: HUEQ0281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other