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

Catalog Number 0057570

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 04/06/2021

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 258381784
• Report Number: 1213643-2021-20097
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00801741065255
• UDI-Public: (01)00801741065255
• Combination Product (y/n): N
• PMA/PMN Number: K942886
• 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: 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
• Device Operator: 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 Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other