C.R. BARD, INC. (BASD) -3006260740 DOT PG PRO 22G 8CM RT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number N/A |
Device Problems
Difficult to Insert (1316); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 06/07/2023 |
Event Type
Injury
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Event Description
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It was reported by the customer that midline got stuck in the patient.The surgeon had to come and remove it.Additional info received on 15-june-23: surgery had to be called to remove catheter.The event happened at time of placement.When inserting the midline, the guidewire and catheter advanced without any resistance but upon trying to retract the guidewire it would not retract.Heat packs were applied and minimal force to try to pull entire midline out with no success.In fear of a portion of the midline breaking off inside the patient surgery was called for safe removal.Complainant was unsure if the event interrupt the administration of any medication, or cause a clinically significant delay in medication.Ultrasound was used during the event.
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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 device has not been returned to the manufacturer for evaluation.
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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.
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Event Description
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It was reported by the customer that midline got stuck in the patient.The surgeon had to come and remove it.Additional info received on 15-june-2023.Surgery had to be called to remove catheter.The event happened at time of placement.When inserting the midline, the guidewire and catheter advanced without any resistance but upon trying to retract the guidewire it would not retract.Heat packs were applied and minimal force to try to pull entire midline out with no success.In fear of a portion of the midline breaking off inside the patient surgery was called for safe removal.Complainant was unsure if the event interrupt the administration of any medication, or cause a clinically significant delay in medication.Ultrasound was used during the event.
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Event Description
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It was reported by the customer that midline got stuck in the patient.The surgeon had to come and remove it.Additional info received on 15-june-23.Surgery had to be called to remove catheter.The event happened at time of placement.When inserting the midline, the guidewire and catheter advanced without any resistance but upon trying to retract the guidewire it would not retract.Heat packs were applied and minimal force to try to pull entire midline out with no success.In fear of a portion of the midline breaking off inside the patient surgery was called for safe removal.Complainant was unsure if the event interrupt the administration of any medication, or cause a clinically significant delay in medication.Ultrasound was used during the event.
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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.Based on a review of this information, the following was concluded: the complaint of difficulty removing the guidewire of a powerglide pro is confirmed and was determined to be use related.One 22 ga powerglide pro was returned for evaluation.The guidewire in the returned powerglide pro was observed to have disjointed coils throughout the distal end of the guidewire, and the guidewire was observed to have sharp bends coming out of the distal end of the needle.Based on the sharp bends and disjointed coils observed along the returned guidewire of the powerglide pro, the complaint of difficult device removal is confirmed.Insertion into resistance such as tissue can cause damage to the guidewire thus causing difficulty during removal of the guidewire.This complaint will be recorded for future trending and monitoring purposes.
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