MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD DESCARTEX¿ 7L COLLECTOR; SHARPS CONTAINER

Catalog Number 305643

Device Problem Defective Component (2292)

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

Event Date 04/14/2022

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: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd descartex¿ 7l collector lid did not fit or close onto the container.The following information was provided by the initial reporter, translated from (b)(6): "difficulty closing the descartex "plastic collectors", the lid does not fit.This has been going on for some time.It gives the impression that the cap is smaller than the collector.Then, during use, it is not possible to fit, so it is only "overlaid" and when it reaches the limit, we pass the tape to close it.".

Manufacturer Narrative

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 the bd descartex¿ 7l collector lid did not fit or close onto the container.The following information was provided by the initial reporter, translated from portuguese: "difficulty closing the descartex "plastic collectors", the lid does not fit.This has been going on for some time.It gives the impression that the cap is smaller than the collector.Then, during use, it is not possible to fit, so it is only "overlaid" and when it reaches the limit, we pass the tape to close it.".

Manufacturer Narrative

H6: investigation summary: due to no material, batch/lot , or sample being received, investigation could not be performed and the production records could not be evaluated.This complaint of lid will not shut could not be verified and the root cause remains unknown.A device history review could not be completed as no batch number was provided.

Event Description

It was reported that the unspecified bd descartex¿ 7l collector lid did not fit or close onto the container.The following information was provided by the initial reporter, translated from portuguese: "difficulty closing the descartex "plastic collectors", the lid does not fit.This has been going on for some time.It gives the impression that the cap is smaller than the collector.Then, during use, it is not possible to fit, so it is only "overlaid" and when it reaches the limit, we pass the tape to close it.".

Manufacturer Narrative

Additional information was provided by the customer.The following fields have been updated: b.5.Describe event or problem: it was reported that the bd descartex¿ 7l collector lid did not fit or close onto the container.D.1.Medical device brand name: bd descartex¿ 7l collector.D.2.Medical device catalog#: 305643.D.2.Medical device lot#: 2118502.D.3.Medical device manufacturer: becton dickinson ind.Cirurgicas ltda.D.4.Medical device expiration date: na.D.5.Unique identifier (udi) #: (b)(4).G.2.Manufacturing location: becton dickinson ind.Cirurgicas ltda.G.5.Pma / 510(k)#: na.H.4.Device manufacture date: 28-apr-2022.

Event Description

It was reported that the bd descartex¿ 7l collector lid did not fit or close onto the container.The following information was provided by the initial reporter, translated from portuguese: "difficulty closing the descartex "plastic collectors", the lid does not fit.This has been going on for some time.It gives the impression that the cap is smaller than the collector.Then, during use, it is not possible to fit, so it is only "overlaid" and when it reaches the limit, we pass the tape to close it.".

• Brand Name: BD DESCARTEX¿ 7L COLLECTOR
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba NJ 07417
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14316801
• MDR Text Key: 291220027
• Report Number: 2243072-2022-00641
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: UNKNOWN
• 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,Followup,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305643
• Device Lot Number: 2118502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1