Model Number PS12508 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 04/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 17-jul-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health 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 halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).The device was not returned.
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Event Description
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Procedure: unknown.Cathplace: pre-peritoneal space.It was reported a catheter break occurred.The physician stated the soaker catheter broke and was left in the patient's body.Additional information received 09-jul-2018 stated the doctor was unable to find the remainder of the catheter inside the patient.Additional information received 13-jul-2018 stated the hospital was uncertain if the broken catheter was inside the patient.Additional information received 15-jul-2018 stated the soaker catheter was placed at the pre-peritoneal space and was removed by the physician.'it was broken inside of the patient." there was no reported injury.
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Manufacturer Narrative
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The device history record for the reported lot number: 0202760059, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 17-aug-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health 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 halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint: (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.
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Manufacturer Narrative
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All information reasonably known as of 22-aug-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health 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 halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.
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Event Description
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Additional information received 23-aug-2018 stated the date of the procedure was (b)(6) 2018.The surgical procedure was an open cholecystectomy.No blunt tip needle was used for the abdominal wall closure.The catheter was secured on the patient with prolene stitch to the skin, the prolene was wound on the catheter.
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Search Alerts/Recalls
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