BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)
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Event Date 08/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recv1911 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported the patient needed long-term treatment and received chemotherapy drugs.In (b)(6) 2020, a picc catheter was placed in the left upper limb.The catheter was placed smoothly.The catheter was placed 38 cm in length.No complications occurred during use.The picc catheter has been used for more than 6 months, and the eight cycles of chemotherapy have ended.Picc extubation was performed at 16:00 on august 6 as ordered by the doctor.The color doppler ultrasound results of the patient before extubation showed that there was no obvious abnormality and no thrombosis at the left upper limb catheterization.When the catheter was pulled out, resistance was found to suspend the operation, and air bubbles were found to be drawn back with a syringe, indicating that the catheter was broken.When the saline injection was used again, two fractures were found, one with obvious leakage at 27 cm of the leakage catheter, and the second with obvious leakage at the puncture point, indicating that there was fracture in the catheter that was not pulled out.Additional information received 2020/09/10: it was reported that after the completion of treatment, multiple attempts to remove the catheter placed in this patient all failed.It ended up with catheter rupture in the body of this patient.
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Event Description
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It was reported the patient needed long-term treatment and received chemotherapy drugs.In (b)(6) 2020, a picc catheter was placed in the left upper limb.The catheter was placed smoothly.The catheter was placed 38 cm in length.No complications occurred during use.The picc catheter has been used for more than 6 months, and the eight cycles of chemotherapy have ended.Picc extubation was performed at 16:00 on (b)(6) as ordered by the doctor.The color doppler ultrasound results of the patient before extubation showed that there was no obvious abnormality and no thrombosis at the left upper limb catheterization.When the catheter was pulled out, resistance was found to suspend the operation, and air bubbles were found to be drawn back with a syringe, indicating that the catheter was broken.When the saline injection was used again, two fractures were found, one with obvious leakage at 27 cm of the leakage catheter, and the second with obvious leakage at the puncture point, indicating that there was fracture in the catheter that was not pulled out.Additional information received 2020/09/10: it was reported that after the completion of treatment, multiple attempts to remove the catheter placed in this patient all failed.It ended up with catheter rupture in the body of this patient.
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Manufacturer Narrative
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H11: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.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter is confirmed.One 4 fr groshong nxt clearvue catheter was returned for evaluation.An initial visual observation showed the catheter was returned in four segments, and use residue was observed on the returned sample.Damage was observed on the middle distal catheter segment between the 26 cm and 27 cm depth markers.Tensile weakness was observed in the middle distal segment at its distal end and at the site of the observed damage.A microscopic observation revealed a slightly curved longitudinal split in the middle distal catheter segment between the 26 cm and 27 cm depth markers.The edges of this split were observed to be somewhat rough but mostly straight, and the fracture surface was observed to be mostly flat and granular in texture.A superficial split with somewhat rounded edges and what appears to be abrasive damage at the corners was observed just distal to this split; this damage may have been caused by repeated kinking of the catheter at this location.The surfaces of the distal end of the middle distal catheter segment and the proximal end of the most distal catheter segment were observed to be partially granular and partially rough and uneven, suggesting the catheter was damaged at this location and ultimately broke completely due to tensile forces.The characteristics of the longitudinal split in one of the catheter segments returned for evaluation indicate the catheter was damaged due to over-pressurization of the catheter (burst damage).This can occur through the use of syringes smaller than 10 ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.The product ifu states: ¿do not flush against resistance,¿ ¿do not use a syringe smaller than 10 ml!¿ and ¿use suture wings to secure the catheter without compromising catheter patency.¿.
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