MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SIMPULSE SOLO SUCTION IRRIGATOR; LAVAGE, JET

Catalog Number	0067700
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, simpulse solo suction was leaking.Preliminary evaluation of the returned sample finds that fluid leak was identified presenting from small holes in the irrigation tubing.These holes presented when the cojoined tubing was separated at point of use.Review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of the manufacturing records was performed and found that the lot was manufactured to specification.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.
Event or Problem Description
As reported, the simpulse solo suction/irrigation device was leaking.It was also reported that the leakage occurred at the perforation in the tubing.There was no reported patient injury.
Event or Problem Description
As reported, the simpulse solo suction/irrigation device was leaking.It was also reported that the leakage occurred at the perforation in the tubing.There was no reported patient injury.
Event or Problem Description
As reported, the simpulse solo suction/irrigation device was leaking.It was also reported that the leakage occurred at the perforation in the tubing.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, simpulse solo suction was leaking.Preliminary evaluation of the returned sample finds that fluid leak was identified presenting from small holes in the irrigation tubing.These holes presented when the cojoined tubing was separated at point of use.Review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of the manufacturing records was performed and found that the lot was manufactured to specification.Addendum: this supplemental mdr is submitted to document the sample evaluation results.Evaluation of the returned sample confirms the fluid leak is presenting from small holes along the irrigation tubing from the two returned used devices.The third lot sample received was evaluated finding no resistance when separating the co-joined tubing and no damage presented.Based on the investigation performed, the most probable root cause is due to the excessive pulling/forces applied when separating the co-joined tubing resulting in perforations presenting in the irrigation tubing.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.
Additional Manufacturer Narrative
As reported, simpulse solo suction was leaking.Preliminary evaluation of the returned sample finds that fluid leak was identified presenting from small holes in the irrigation tubing.These holes presented when the cojoined tubing was separated at point of use.Review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of the manufacturing records was performed and found that the lot was manufactured to specification.Addendum: this supplemental mdr is submitted to document the sample evaluation results.Evaluation of the returned sample confirms the fluid leak is presenting from small holes along the irrigation tubing from the two returned used devices.The third lot sample received was evaluated finding no resistance when separating the co-joined tubing and no damage presented.Based on the investigation performed, the most probable root cause is due to the excessive pulling/forces applied when separating the co-joined tubing resulting in perforations presenting in the irrigation tubing.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.

• Brand Name: SIMPULSE SOLO SUCTION IRRIGATOR
• 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 ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 19519077
• Report Number: 1213643-2024-00297
• Device Sequence Number: 12282139
• Product Code: FQH
• UDI-Device Identifier: 00801741000379
• UDI-Public: (01)00801741000379
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K942886
• 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): 06/17/2024

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 Catalogue Number: 0067700
• Device Lot Number: JUJQ0390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• 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