TERUMO PHILIPPINES CORPORATION TERUMO SURFLO INTRAVENOUS CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number N/A |
Device Problems
Break (1069); Dent in Material (2526)
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Patient Problems
Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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Event Date 03/08/2019 |
Event Type
Injury
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Manufacturer Narrative
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Lot number - potential lot numbers 180831sa / 180602sd.Udi - the corresponding lot is not subjected for udi.Expiration date - 07-31-2023 / 05-31-2023.Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: distributor.Device manufacture date - 08-31-2018 / 06-02-2018.The actual device has been returned to the manufacturing facility.Based on the results of our investigation, the root cause of the complaint could not be identified.Received actual sample showed a broken iv catheter with deterioration occurred on the tube wherein original shape (round) becomes flattened, deformed and dent was noted.A portion on the tip of the catheter tube that remained on the hub was observed cleaned cut but there is also a portion that showed slight elongation.With this, we cannot clearly determine the root cause of the complaint.However, as informed through the complaint details and additional information, the broken catheter tube was reported after 12 days which indicated that the catheter tube was used affectively prior the occurrence of breakage.Verification on retention sample of potential lots showed no defects found such as crack, pinhole, scratch, bent and broken parts on catheter tube that would lead to catheter tube breakage.No damaged or deformed catheter tube that might lead to the complaint.Retention samples of potential lots showed were also evaluated for catheter tube and catheter hub fitting force.All samples passed.We also have 2 stages of 100% visual inspection which covers the overall condition of the product and our production runs under validated parameters.In addition, lot history file of potential lots showed that no non-conformities or troubles related to the complaint was encountered.Furthermore, qc conducts visual inspection to check product quality prior shipment.No nonconformity related to the complaint was noted.(b)(4).
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Event Description
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The user facility reported that after anesthesiologist, the iv catheter and patient was sent to csicu (cardiovascular surgery icu) the nurse checked the iv catheter and found that the canuale had been broken in the body after treatment.The broken part has been taken out and the patient has been discharged from hospital.The broken catheter was still in the body was not removed.The doctor decided not to take the broken catheter out because patient had a thrombocytopenia and was focused on the aortic dissection treatment.The hospital plans to take the broken catheter out when the patient returns to hospital end of (b)(6).Additional information received as of (b)(6) 2019: it was reported that the hospital proceed the surgical intervention to remove the broken catheter tube from patient.Additional information received as of (b)(6) 2019: the patient's disease was an aortic dissection and went to emergency room.The insertion of iv catheter was in the radial artery at the operating room by anesthesiologist on (b)(6) 2019.The patient was transferred to cvsicu on (b)(6) 2019 and that's when the nurse found the catheter was broken.The broken catheter was still kept in the body, it was not removed.The patient was discharged on (b)(6) 2019 and the hospital plans to take the broken catheter out when patient returns to the hospital around end of (b)(6).
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Manufacturer Narrative
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This report is being submitted as follow up no.2 to provide the additional device return date and to provide the completed investigation results on the remaining piece of the device that was sent back on july 25, 2019.A distal portion of the actual sample was received.The center portion of the tube was evidently pinched which result to be flattened and an obvious dent was observed near the deteriorated tip of the broken end.The exact description cannot be confirmed since received contaminated actual sample was not subjected to further evaluation.With this, we still cannot determine the root cause of the complaint.
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Manufacturer Narrative
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A reference photo was provided and showed the remaining broken catheter tube that was taken out from patient.Due to quality limitation of the photo, details of the sample description cannot be confirmed but an evident deterioration on the tip of the broken end was observed.Based on the formed appearance, a bent or dent was noted.
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Event Description
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Additional information was received on june 27, 2019: it was confirmed that the remaining part of the broken catheter tube was taken out of the patient.
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