MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SIMPULSE SOLO SUCTION IRRIGATOR TIP; LAVAGE, JET

Catalog Number 0067621

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

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

The subject products have not been returned for evaluation.Photos of the foreign matter were provided for review.The photos confirm that there is foreign matter within the sealed packages.As the foreign matter was present in the package prior to sealing the lid to the tray, root cause is most likely due to manufacturing; however, without the samples to evaluate, the origin of the foreign matter cannot be determined.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This is the first reported complaint for the subject lot of (b)(4) units manufactured in june of 2019.An emdr will be submitted for each of the five devices.This report represents the fifth of the five devices.Samples not received to date.

Event Description

It was reported that before opening the sterilized package, dust was allegedly found in the sterilized package.The product reference number is supplied in a case of 10.As reported, 5 devices of the case of 10 were noted to have a "dust" inside the packaging.All of the packages were unopened.There was no damage noted to the product or shipping packages.There was no reported patient involvement.

Event Description

It was reported that before opening the sterilized package, dust was allegedly found in the sterilized package.The product reference number is supplied in a case of 10.As reported, 5 devices of the case of 10 were noted to have a "dust" inside the packaging.All of the packages were unopened.There was no damage noted to the product or shipping packages.There was no reported patient involvement.

Manufacturer Narrative

The subject products have not been returned for evaluation.Photos of the foreign matter were provided for review.The photos confirm that there is foreign matter within the sealed packages.As the foreign matter was present in the package prior to sealing the lid to the tray, root cause is most likely due to manufacturing; however, without the samples to evaluate, the origin of the foreign matter cannot be determined.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This is the first reported complaint for the subject lot of 140 units manufactured in june of 2019.An emdr will be submitted for each of the five devices.This report represents the fifth of the five devices.This is an addendum to the initial emdr to document the return and evaluation of the sample.The samples were returned sealed in the original packaging.Evaluation identified black/ brown foreign material in 1 of the 5 sealed showerhead tip product pouches.The foreign matter is of unknown origin.As the material was found to be in the sealed product pouch, root cause is determined to be related to manufacturing.Notification / awareness training was provided to the operators.A 24 month review of complaints identifies no other complaints of this nature have been reported to this product.This semdr represents the fifth of the five devices which is unconfirmed for the reported event.Four additional semdr have been submitted to document the sample evaluation results.Updated fields: b4, d10, g1, g2, g4, g7, 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.

• Brand Name: SIMPULSE SOLO SUCTION IRRIGATOR TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9973087
• MDR Text Key: 189743978
• Report Number: 1213643-2020-03649
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00801741010279
• UDI-Public: (01)00801741010279
• Combination Product (y/n): N
• PMA/PMN Number: K942886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0067621
• Device Lot Number: JUDSF589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1