MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SOFT SPLASH SHIELD WITH SHOWERHEAD TIP; LAVAGE, JET

Catalog Number	0057730
Medical Device Problem Codes	Inability to Irrigate (1337); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the simpulse plus tip detached during the procedure.Visual evaluation of the returned sample confirms the showerhead tip detached as reported.There is no physical damage, and no signs excessive force was applied to the tip while in use.Visual evaluation finds little to no cyclohexanone.Based on the sample evaluation and investigation performed, the showerhead body is found to have detached from the irrigation tube due to the lack of cyclohexanone that adheres the spray tip to the irrigation tube; the root cause is found to be manufacturing related.
Event or Problem Description
As reported, on (b)(6) 2021, the bard/davol simpulse plus tip detached and failed to irrigate while attempting to perform a wound washout procedure on a patient.It was reported that water could not be drained due to detached tip of the device.The air pressure was approximately 50 psi.As reported, there was no delay in completing the procedure and no reported patient injury.

• Brand Name: SOFT SPLASH SHIELD WITH SHOWERHEAD TIP
• Common Device Name: LAVAGE, JET
• 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 ; san geronimo industrial park; lot #1, road #3, km 79.7; humacao, PR 00791 ; 7876565500
• MDR Report Key: 12843864
• Report Number: 1213643-2021-20427
• Device Sequence Number: 4429989
• Product Code: FQH
• UDI-Device Identifier: 00801741010422
• UDI-Public: (01)00801741010422
• 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: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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: 09/28/2025
• Device Catalogue Number: 0057730
• Device Lot Number: JUEX1914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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