Catalog Number 305490 |
Device Problem
Device Misassembled During Manufacturing /Shipping (2912)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 09/11/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.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.Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
|
|
Event Description
|
Material no.: 305490 batch no.: 8338003.It was reported that before use of the sharps coll 8.2qt red vented cap the lid of the sharps container was discovered broken in box.The following information was provided by the initial reporter: lid of sharps container broken when package was opened.No damage to outside of box or other products inside box.
|
|
Event Description
|
Material no.: 305490.Batch no.: 8338003.It was reported that before use of the sharps coll 8.2qt red vented cap the lid of the sharps container was discovered broken in box.The following information was provided by the initial reporter: lid of sharps container broken when package was opened.No damage to outside of box or other products inside box.
|
|
Manufacturer Narrative
|
H.6.Investigation summary: an investigation could not be completed as not enough information is available.Pictures shows damage to the cap however picture also shows bottle was in a single pack box not the original 12pcs box that pps would have used (pps packs this product 12 per box never single packs).No ncr's were raised during the production of this lot.All testing was within specification.The manufacturer believes that if the product was repackaged and shipped the damage most likely occurred then.The root cause is related to a distributor; repacking and distribution, or damage during repackaging or shipping.No capa is required at this time.The supplier has notified operators to look for any deformities with caps.H3 other text : see section h.10.
|
|
Search Alerts/Recalls
|