B. BRAUN MEDICAL INC. INTROCAN SAFETY; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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Model Number 4251644-02 |
Device Problems
Fail-Safe Problem (2936); Device Handling Problem (3265)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 12/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.It should be noted that although the exact batch number is unknown, the following potential batch numbers were provided: lot 0061735860; manufactured: 10/05/2020, expiration: 09/30/2025.Lot 0061727004; manufactured: 09/23/2020, expiration: 08/31/2025.
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Event Description
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As reported by the user facility: "a nurse started an iv and it did not work.The safety clip deployed.While cleaning up, the nurse was stuck in the finger by the needle.".
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number 400499104.One used sample without packaging was returned for evaluation.The complaint sample was reviewed by the product smes and extensive damage was noted on the clip.The clip appeared to be crushed to the extent where the arms were forced open.While damage can occur during the processing of the piece, it is unlikely that the defect was caused by the process.All units are 100% visually inspected by the clip inspection station.A piece with that amount of damage would be rejected immediately.Additionally, the needle guard would not fit over the clip if it was damaged in the way that was observed.Therefore, the component would not have passed through the guard load station without triggering a fault.It is the conclusion of the smes that the damage to the clip occurred outside of the b.Braun manufacturing facility.The reported defect was not confirmed.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
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