Catalog Number 386806 |
Device Problem
Material Separation (1562)
|
Patient Problem
Phlebitis (2004)
|
Event Date 07/18/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that 50 of the bd cathena¿ safety iv catheter with bd multiguard¿ technology experienced component separation.The following information was provided by the initial reporter, translated from spanish to english: devices connected to the catheter are disconnected after a period of time.".
|
|
Manufacturer Narrative
|
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: unknown d4.Medical device expiration date: unknown h4.Device manufacture date: unknown h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported that 50 of the bd cathena¿ safety iv catheter with bd multiguard¿ technology experienced component separation.The following information was provided by the initial reporter, translated from spanish to english: devices connected to the catheter are disconnected after a period of time.".
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 10-aug-2023 h6: investigation summary our quality engineer inspected the 1 representative sample submitted for evaluation.The reported issues of leakage at insertion site and separation catheter from adapter were not confirmed upon inspection and testing of the sample.Analysis of the sample showed that it had no observable damages or defects.The sample was found to be within manufacturing specifications.The sample also underwent leakage testing, and no leakage was observed.Bd could not determine a manufacturing related root cause since the reported defects were not confirmed during the evaluation of the sample.Production records were reviewed, and this batch meets our manufacturing specification requirements.H3 other text : see h10.
|
|
Search Alerts/Recalls
|