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

Catalog Number	0057621
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• 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: 11564089
• Report Number: 1213643-2021-20060
• Device Sequence Number: 4147681
• Product Code: FQH
• UDI-Device Identifier: 00801741010415
• UDI-Public: (01)00801741010415
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2021

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: 02/28/2025
• Device Catalogue Number: 0057621
• Device Lot Number: JUEQ2402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/24/2021
• 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