C.R. BARD, INC. (BASD) -3006260740 22 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number N/A |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 03/20/2024 |
Event Type
Injury
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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 manufacturer has received the sample and will evaluate.Results are expected soon.
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Event Description
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It was reported, "facility uses powerglide pro midline catheters in its patients and in the medical department (md).On the 20th of this month, during the placement of one of these 22g caliber catheters, lot rehs3824, the tip of the guide wire broke off during its removal and became lodged in the subcutaneous tissue.It should be noted that the technique was carried out by a highly experienced nurse and went off without a hitch.The guide wire went perfectly, but the catheter ended up bending during insertion and when it was removed, the tip broke off and remained completely in the subcutaneous tissue for around 4cm.The incident compromised the patient's care and he was operated on by the surgical department with the need for local exploration, with an opening of around 1.5cm of the skin and subsequent suturing.The same situation had already occurred with another nurse.As the tip of the catheter was visualized, the nurse removed it with forceps.Without any other associated complications." it was reported this occurred with two devices.This report addresses the second device that the nurse removed it with forceps.
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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 complaint of a damaged catheter is confirmed; however, the exact cause is unknown.One photograph of a powerglide pro catheter was returned for evaluation.An initial visual observation of the photograph showed that the tubing of a powerglide pro catheter was significantly shorter than the length of the unused catheter placed next to it in the returned photograph.Use residues were observed on the sample in the returned photograph.There appeared to be a complete break in the catheter.There were no distinguishing features in the returned photograph of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
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Event Description
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It was reported, "facility uses powerglide pro midline catheters in its patients and in the medical department (md).On the 20th of this month, during the placement of one of these 22g caliber catheters, lot rehs3824, the tip of the guide wire broke off during its removal and became lodged in the subcutaneous tissue.It should be noted that the technique was carried out by a highly experienced nurse and went off without a hitch.The guide wire went perfectly, but the catheter ended up bending during insertion and when it was removed, the tip broke off and remained completely in the subcutaneous tissue for around 4cm.The incident compromised the patient's care and he was operated on by the surgical department with the need for local exploration, with an opening of around 1.5cm of the skin and subsequent suturing.The same situation had already occurred with another nurse.As the tip of the catheter was visualized, the nurse removed it with forceps.Without any other associated complications." it was reported this occurred with two devices.This report addresses the second device that the nurse removed it with forceps.
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Search Alerts/Recalls
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