MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA SHARPS COLL II BD 7L; SHARPS CONTAINER

Catalog Number 305643

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: no root cause can be determined as no samples were received.Rationale: since no samples displaying the reported condition were received corrective actions are not necessary.

Event Description

It was reported that unspecified bd¿ sharps container top cover is not sealing properly.This was discovered during use.The following information was provided by the initial reporter: top cover is not sealing properly.

Manufacturer Narrative

The following fields have been updated with corrections: site legal name (fda): becton dickinson ind.Cirurgicas ltda.Curitiba, brazil / 81170-230.B.5.Describe event or problem: the event description has been updated with a new medical device brand name.It was reported that sharps coll ii bd 7l top cover is not sealing properly.This was discovered during use.The following information was provided by the initial reporter: top cover is not sealing properly.D.1.Medical device brand name: sharps coll ii bd 7l d.3.Medical device manufacturer: curitiba d.2.Medical device catalog #: 305643 d.4.Medical device expiration date: na.D.4.Medical device lot #: 9260587 d.4.Unique identifier (udi) #: (b)(4).G.1.Manufacturing location: curitiba.H.4.Device manufacture date: 2019-09-17.

Event Description

It was reported that sharps coll ii bd 7l top cover is not sealing properly.This was discovered during use.The following information was provided by the initial reporter: top cover is not sealing properly.

• Brand Name: SHARPS COLL II BD 7L
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba NJ 07417
• MDR Report Key: 10008180
• MDR Text Key: 190145155
• Report Number: 2243072-2020-00695
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305643
• Device Lot Number: 9260587
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other