Catalog Number 302438 |
Device Problem
Volume Accuracy Problem (1675)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/27/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.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 491 bd discardit¿ syringes had scale marking issues/missing scale markings.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "marking defects.".
|
|
Manufacturer Narrative
|
H6: investigation summary: the photos were received by bd for evaluation.A quality engineer was able to review the photos of a discardit 2ml with 25gx1 from lot # 1121609 regarding item # 302438 with the reported issue of marking defects.The defects of ink marking no samples received from customer hence, defect cannot be confirmed.The dhr of material number 302438 and lot number 1121609 was checked and no quality notifications were recorded on this lot.The investigating team also used the retention samples of material code 302438 and lot number 1121609 for investigating the reported defect.H3 other text : see h10.
|
|
Event Description
|
It was reported that 491 bd discardit¿ syringes had scale marking issues/missing scale markings.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "marking defects".
|
|
Search Alerts/Recalls
|