Catalog Number 381023 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2022 |
Event Type
malfunction
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Event Description
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It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga there were connection issues.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a connection issue of iagbc to syringe.According to the customer's report, after venipuncture in an outpatient radiology room, the hcp attached a syringe to the iagbc but the syringe did not fit it.
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 04-jan-2023.H6: investigation summary our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one used 22g insyte autoguard bc pro catheter assembly with no product documentation to indicate the reference or lot number.Additionally, four photos were provided for investigation.A gross visual inspection of the returned unit found that the luer threads were deformed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to a misalignment of the adapter relative to the equipment.Alignment of the stations is performed by operators during setup and downtime as deemed applicable by the quality plan.Additionally, sampling is performed by operators to search for damage to the adapter per the sampling plan.Preventative maintenance (pm) is also performed to ensure the equipment is running properly.Pm records were verified to be up to date during the production of this lot.In addition, a device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
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Event Description
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It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga there were connection issues.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a connection issue of iagbc to syringe.According to the customer's report, after venipuncture in an outpatient radiology room, the hcp attached a syringe to the iagbc but the syringe did not fit it.
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Search Alerts/Recalls
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