MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SIMPULSE PLUS IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0057570
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated, it has not get begun.To date, this is the only reported complaint for this manufacturing lot.When the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
As reported, during the setup of a procedure on (b)(6) 2021, the bard/davol simpulse plus irrigator leaked saline because the connector near the saline solution inflow was poorly connected.In addition, when pressure was applied, the connection suddenly came off.Another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated, it has not get begun.To date, this is the only reported complaint for this manufacturing lot.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the results of sample evaluation.The subject device was returned for evaluation.Evaluation of the sample finds that the pump body is separated in half at the weld which would result in a fluid leak as reported.It is likely the pump housing was misaligned during the manufacturing process resulting in the separation of the housing halves during use.Review of manufacturing records indicate product was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in december 2019.Based on the sample evaluation and investigation performed, the root cause is determined to be manufacturing related.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 or Problem Description
As reported, during the setup of a procedure on (b)(6) 2021, the bard/davol simpulse plus irrigator leaked saline because the connector near the saline solution inflow was poorly connected.In addition, when pressure was applied, the connection suddenly came off.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: SIMPULSE PLUS IRRIGATOR
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11744751
• Report Number: 1213643-2021-20097
• Device Sequence Number: 11829330
• Product Code: FQH
• UDI-Device Identifier: 00801741065255
• UDI-Public: (01)00801741065255
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2022
• Device Catalogue Number: 0057570
• Device Lot Number: JUDY1826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other