|
Model Number EV14 |
Device Problems
Device Damaged Prior to Use (2284); Packaging Problem (3007)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/17/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2022).
|
|
Event Description
|
It was reported that prior to a biopsy procedure, the package was allegedly found to be damaged.There was no patient contact.
|
|
Event Description
|
It was reported that prior to a biopsy procedure, the package was allegedly found damaged.There was no reported patient contact.
|
|
Manufacturer Narrative
|
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiry date: 01/2022), h11: h6(device, method), h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|
|
Manufacturer Narrative
|
H10: additional information was received and the reportability was reassessed as malfunction.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned to the manufacturer for evaluation.However, one electronic photo was provided for review.Photo shows the damage to outer packaging where the carton box gets damaged.Therefore, based on the photo review, the reported packaging problem can be confirmed for the reported failure.Five sealed lot elevation biopsy probes, inside outer packaging, were returned for evaluation.On visual evaluation , the packaging carton was noted to be damaged.Also, there was no damage or evidence of breach of sterile barrier.Therefore the investigation for the reported packaging problem is confirmed as the outer package was found to be damaged.A definitive root cause for the alleged packaging problem could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 01/2022), g3 h11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|
|
Event Description
|
It was reported that prior to a biopsy procedure, the package was allegedly found damaged.There was no patient contact.
|
|
Search Alerts/Recalls
|
|
|