MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLL TROLY FOOT-OP 9GAL RECYKLEEN; SHARPS DISPOSAL

Catalog Number 305091

Device Problem Break (1069)

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

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.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.(b)(6).Medical device expiration date: unknown.Device manufacture date: unknown.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 the cart wire of two bd¿ sharps coll troly foot-op 9gal recykleen were damaged.Customer¿s verbatim: ¿the cart wire was damaged.¿.

Manufacturer Narrative

H.6.Investigation: the dhr review process was not performed due to the lot number was not provided.According with this investigation there is no enough information available to perform an exhaustive investigation due to no samples or pictures were provided in this complaint.Based on information provided it was not possible determine the root cause like a failure mode related to the manufacturing process since there is not enough information related to this failure mode.

Event Description

It was reported that the cart wire of two bd¿ sharps coll troly foot-op 9gal recykleen were damaged.Customer¿s verbatim: ¿ the cart wire was damaged.¿.

• Brand Name: BD¿ SHARPS COLL TROLY FOOT-OP 9GAL RECYKLEEN
• Type of Device: SHARPS DISPOSAL
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8428278
• MDR Text Key: 139213499
• Report Number: 2243072-2019-00504
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305091
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other