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

Catalog Number 0057621

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

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned for evaluation.Visual evaluation confirms the reported event of a brown colored foreign debris inside of the sealed pouch; however, the origin of the foreign matter could not be determined.As the foreign matter was present in the package prior to sealing, this presented at the time of manufacturing and is confirmed for a manufacturing related condition.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 may, 2020.

Event Description

It was reported by the user facility contact that foreign material was noted prior to opening the package of the bard/davol simpulse plus irrigator on (b)(6) 2021.There was no reported patient involvement.

• Brand Name: SIMPULSE PLUS W/SHOWERHEAD
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 11564089
• MDR Text Key: 243820268
• Report Number: 1213643-2021-20060
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00801741010415
• UDI-Public: (01)00801741010415
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K830386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0057621
• Device Lot Number: JUEQ2402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2020
• 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