MAUDE Adverse Event Report: BECTON DICKINSON BD RECYKLEEN¿ SHARPS CABINET LOCKING WALL MOUNT; SHARPS CONTAINER

Catalog Number 305097

Device Problem Break (1069)

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

Event Date 06/07/2023

Event Type  malfunction  

Event Description

It was reported that during use with bd recykleen¿ sharps cabinet locking wall mount the key broke off in the lid lock.The following information was provided by the initial reporter: keys have broken off inside the sharps container lock.

Manufacturer Narrative

The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 during use with bd recykleen¿ sharps cabinet locking wall mount the the key broke off in the lid lock.The following information was provided by the initial reporter: keys have broken off inside the sharps container lock.

Manufacturer Narrative

H6: investigation summary the actual sample is unavailable for investigation.Photo is provided for verification.It was reported by customer that the recykleen cabinet and a key broke in the lock.Investigation performed on basis of photo representation.Notified to supplier and response received with further investigation performed.Device history record (dhr) for part # 305097 has been revised and analyzed.All quality records indicate that all inspections and tests required by the manufacturing assembly procedure, in process and final inspection procedures were performed and were met, also no internal ncmr or any issued reported in the manufacturing of this batch (#: 2131021) was founded.However, a functional failure was found by our customer and apparently the cabinet arrived with a key broke in the lock.The most probable cause for ¿broken key issue¿ we consider to be during use the key was handled with too much force by the final user during its operation.Due to no history records about broken key problems and we don't have physical sample reference; root cause could not be defined completely.See h10.

Event Description

It was reported that during use with bd recykleen¿ sharps cabinet locking wall mount the the key broke off in the lid lock.The following information was provided by the initial reporter: keys have broken off inside the sharps container lock.

Manufacturer Narrative

H6: investigation summary the actual sample is unavailable for investigation.Photo is provided for verification.It was reported by customer that the recykleen cabinet and a key broke in the lock.Investigation performed on basis of photo representation.Notified to supplier and response received with further investigation performed.Device history record (dhr) for part # 305097 has been revised and analyzed.All quality records indicate that all inspections and tests required by the manufacturing assembly procedure, in process and final inspection procedures were performed and were met, also no internal ncmr or any issued reported in the manufacturing of this batch (#: 2131021) was founded.However, a functional failure was found by our customer and apparently the cabinet arrived with a key broke in the lock.Potential root cause will be: the most probable cause for ¿broken key issue¿ we consider to be during use the key was handled with too much force by the final user during its operation.Due to no history records about broken key problems and we don't have physical sample reference; root cause could not be defined completely.Containment actions after receiving the notifications of non-conformance, the following actions were considered: 1.Quality alert was created, requesting to be carefully with key handling and non-broken confirmation.2.Meetings were held with all key members involved in the bd-products assembly process line and were inform of the failures found, an attendance record was issued as documented evidence of such notification.Conclusion: quality alert was created, requesting to be carefully with key handling and non-broken confirmation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD RECYKLEEN¿ SHARPS CABINET LOCKING WALL MOUNT
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17222371
• MDR Text Key: 318962118
• Report Number: 2243072-2023-01145
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305097
• Device Lot Number: 2138021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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