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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the simpulse plus shower head tips suction/irrigation device was used during incision and drainage (i&d) of knee which the fluid in a 3 l ns bag hanging off an iv pole would not stop flowing through device as soon as the bag is spiked at times.It was reported that usually they set the psi no greater than 120 mmhg.It was also reported that fluid came out of the exhaust line and the pressure relief valve popped out.The device worked fine sometimes throughout the case and then would fail.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the simpulse plus suction/irrigation device had fluid leak.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.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 : not returned.
Additional Manufacturer Narrative
As reported, the simpulse plus suction/irrigation device had fluid leak.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to correct the medical device expiration date.Updated fields: b4, g3, g6, h2, h10, h11.Corrected field: d4 (medical device expiration date) 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 : not returned.
Event or Problem Description
As reported, the simpulse plus shower head tips suction/irrigation device was used during incision and drainage (i&d) of knee which the fluid in a 3 l ns bag hanging off an iv pole would not stop flowing through device as soon as the bag is spiked at times.It was reported that usually they set the psi no greater than 120 mmhg.It was also reported that fluid came out of the exhaust line and the pressure relief valve popped out.The device worked fine sometimes throughout the case and then would fail.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
• 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: 17630979
• Report Number: 1213643-2023-00316
• Device Sequence Number: 12685569
• Product Code: FQH
• UDI-Device Identifier: 00801741065255
• UDI-Public: (01)00801741065255
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K830386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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: 01/28/2026
• Device Catalogue Number: 0057570
• Device Lot Number: JUHN8036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown