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

Catalog Number	0067700
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the subject product has not been made available for evaluation.Based on the available information and without a sample to evaluate, we are unable to determine the root cause of the reported grease seeping from the hand piece.If additional event information is obtained, or if the sample is returned for evaluation, this report will be updated.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of 1200 units released for distribution in december of 2018.
Event or Problem Description
It was reported by the user facility that what was described as grease was allegedly seeping out from the hand piece of the simpulse solo irrigator.The scrub nurse identified the issue when she picked up the product for during set up.She was able to replace it with a new item to use in the case and the subject product was not used on the patient.No patient impact.
Event or Problem Description
It was reported by the user facility that what was described as grease was allegedly seeping out from the hand piece of the simpulse solo irrigator.The scrub nurse identified the issue when she picked up the product for during set up.She was able to replace it with a new item to use in the case and the subject product was not used on the patient.No patient impact.
Additional Manufacturer Narrative
To date, the subject product has not been made available for evaluation.Based on the available information and without a sample to evaluate, we are unable to determine the root cause of the reported grease seeping from the hand piece.If additional event information is obtained, or if the sample is returned for evaluation, this report will be updated.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in december of 2018.Addendum per sample evaluation: a visual evaluation of the subject product was performed.A small amount of the white food grade grease used in the manufacturing process is visible on the trigger.The device was opened to observe the grease placement inside of the handle.Grease was noted to be in the proper locations and was not applied in excess.The white food grade grease is applied during multiple steps in the manufacturing process.The grease is found to have been transferred to the trigger during one of these processes.Root cause is manufacturing related.

• Brand Name: SIMPULSE SOLO SUCTION IRRIGATOR
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8519947
• Report Number: 1213643-2019-03053
• Device Sequence Number: 1474639
• Product Code: FQH
• UDI-Device Identifier: 00801741000379
• UDI-Public: (01)00801741000379
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: 10/28/2021
• Device Catalogue Number: 0067700
• Device Lot Number: JUCYF347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1