Catalog Number 386804 |
Device Problem
Defective Component (2292)
|
Patient Problem
Phlebitis (2004)
|
Event Date 07/18/2023 |
Event Type
malfunction
|
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: d.4.Medical device lot #: 2329609.D.4.Medical device expiration date: 30-nov-2022.H.4.Device manufacture date: 28-nov-2022.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 the bd cathena¿ safety iv catheter was defective.The following information was provided by the initial reporter, translated from spanish to english: defective: "after successful insertion, if blood collection is required, it is necessary to remove part of the catheter.".
|
|
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.Our quality engineer inspected the 2 representative samples submitted for evaluation.The reported issue of catheter defective / damaged was not confirmed upon inspection and testing of the samples.Analysis of the samples showed that they had no observable damages or defects.All of the samples were found to be within manufacturing specifications.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the samples.Production records were reviewed, and this batch meets our manufacturing specification requirements.H3 other text : see h10.
|
|
Event Description
|
It was reported that the bd cathena¿ safety iv catheter was defective.The following information was provided by the initial reporter, translated from spanish to english: defective: "after successful insertion, if blood collection is required, it is necessary to remove part of the catheter.".
|
|
Search Alerts/Recalls
|