DAVOL INC., SUB. C.R. BARD, INC. -1213643 SIMPULSE PLUS IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Catalog Number 0057570 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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As reported, the simpulse plus shower head tips suction/irrigation device was used during incision and drainage (i&d) of scrotum 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.
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Manufacturer Narrative
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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.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.
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Event Description
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As reported, the simpulse plus shower head tips suction/irrigation device was used during incision and drainage (i&d) of scrotum 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.
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