MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SHARPS COLL II BD 13L; SHARPS DISPOSAL

Catalog Number 305642

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

It was reported that 7 of the bd sharps coll ii bd 13l experienced difficulties when closing the product, causing the lid to break.The following information was provided by the initial reporter, translated from portuguese to english: the technical team has indicated difficulties when closing the product, causing the lid to break and the need to replace it with a new lid.

Manufacturer Narrative

Initial reporter phone #: (b)(6).Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 1273433.Medical device expiration date: na.Device manufacture date: (b)(6) 2021.Medical device lot #: 1301952.Medical device expiration date: na.Device manufacture date: (b)(6) 2021.Medical device lot #: 1197841.Medical device expiration date: na.Device manufacture date: (b)(6) 2021.

Manufacturer Narrative

H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

It was reported that 7 of the bd sharps coll ii bd 13l experienced difficulties when closing the product, causing the lid to break.The following information was provided by the initial reporter, translated from portuguese to english: the technical team has indicated difficulties when closing the product, causing the lid to break and the need to replace it with a new lid.

• Brand Name: BD SHARPS COLL II BD 13L
• Type of Device: SHARPS DISPOSAL
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16080690
• MDR Text Key: 308445677
• Report Number: 3003916417-2022-00301
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305642
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1