Model Number 367393 |
Device Problem
Shielding Failure (1568)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/29/2022 |
Event Type
malfunction
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Event Description
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It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set, the user identified the sleeve falling off from the device.The following information was provided by the initial reporter.The customer stated: during blood culture collection, the cork-boring needle of the protected epicranial needle used to pierce the tubes was stripped of its protective sleeve.As a result, the patient's blood flowed through the needle.
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Manufacturer Narrative
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There were multiple device types reported to be involved.The information for the additional device types are as follows.Medical device type: jka / fpa.Common device name: blood specimen collection device; intravascular administration set.Lot #: batch 2045597 does not exist for material 367393.Expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set, the user identified the sleeve falling off from the device.The following information was provided by the initial reporter.The customer stated: during blood culture collection, the cork-boring needle of the protected epicranial needle used to pierce the tubes was stripped of its protective sleeve.As a result, the patient's blood flowed through the needle.
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Manufacturer Narrative
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H6: investigation summary bd did not receive samples or photographs from the customer in support of this complaint.Batch: 2045597 provided in support of this complaint is not correct therefore evaluation of retention samples cannot be completed.Bd was unable to duplicate or confirm the customer¿s indicated failure mode.No root cause could be established for the reported defect.The device history records could not be reviewed because lot number is not correct.H3 other text : see h10.
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Search Alerts/Recalls
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