MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL EUROPE 1.5L YEL NEXT GEN; SHARPS COLLECTORS

Catalog Number 305624

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).(b)(6).Device evaluated by mfr: 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 cover breakage occurred with a sharps coll europe 1.5l yel next gen.The following information was provided by the initial reporter: "i come back to you regarding our claim on needle collectors ((b)(4)).We have taken note of your answer that the breakage of the cover is due to a filling limit not respected, response that surprised us.However we did send the information back to our users and despite that, we had a new collector, in march, whose provisional lock broke.The collector for waste with infectious risks is practically empty, so no problem of filling limit (lot 8332001).The opening / closing maneuver is done at the beginning and end of the day so the system is not very used.We have kept the collector related to this complaint.Looking forward to your return.".

Event Description

It was reported that cover breakage occurred with a sharps coll europe 1.5l yel next gen.The following information was provided by the initial reporter, "i come back to you regarding our claim on needle collectors (pr# 667706 and 674144).We have taken note of your answer that the breakage of the cover is due to a filling limit not respected, response that surprised us.However we did send the information back to our users and despite that, we had a new collector, in march, whose provisional lock broke.The collector for waste with infectious risks is practically empty, so no problem of filling limit (lot 8332001).The opening / closing maneuver is done at the beginning and end of the day so the system is not very used.We have kept the collector related to this complaint.Looking forward to your return.".

Manufacturer Narrative

H.6.Investigation: verification of internal stock and no issues found.The picture provided was reviewed and confirmed the customer has a broken lid.This appears to be related to a misuse.The parts are 100% verified and there are no records of this issue.All related complaints were reported by the same user facility.Furthermore, testing was performed with internal sample and confirmed product meets the requirements for the intended use.The root cause was most likely a misuse during handling.H3 other text : see h.10.

• Brand Name: SHARPS COLL EUROPE 1.5L YEL NEXT GEN
• Type of Device: SHARPS COLLECTORS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8608514
• MDR Text Key: 148435474
• Report Number: 2243072-2019-00916
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305624
• Device Lot Number: 8332001
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other