MAUDE Adverse Event Report: BECTON DICKINSON BD¿ EXTRA LARGE SHARPS COLLECTOR SLIDE TOP; SHARPS CONTAINER

Model Number 305609

Device Problem Component Missing (2306)

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

Event Date 03/23/2023

Event Type  malfunction  

Event Description

It was reported that 5 bd¿ extra large sharps collector slide top was missing lids.The following information was provided by the initial reporter: this is regarding the item 305609 for the po 4515231937, our customer ordered 5 cases of this item and all 5 cases were received but they reached us stating that there is no lids for 1 case ( 5 items ) that has been delivered.

Manufacturer Narrative

The manufacturing location for this product is flextronic.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) 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.D.4 device expiration date: unknown.H.4 device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.It was reported by customer that " all 5 cases were received but they reached us stating that there are no lids for 1 case (5 items)" could not be verified due to the product or photos not being returned for failure investigation.A device history record review process to verify if there were issues reported like missing lids during the manufacturing process of this product, was not able to be performed since not lot number was provided.A review of the non-conformance material report was performed; the result showed that no missing lids issues were reported for the same part number throughout the last twelve months within our process.H3 other text : see h10.

Event Description

It was reported that 5 bd¿ extra large sharps collector slide top was missing lids.The following information was provided by the initial reporter: this is regarding the item 305609 for the po (b)(4), our customer ordered 5 cases of this item and all 5 cases were received but they reached us stating that there is no lids for 1 case ( 5 items ) that has been delivered.

• Brand Name: BD¿ EXTRA LARGE SHARPS COLLECTOR SLIDE TOP
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16770686
• MDR Text Key: 313606431
• Report Number: 2243072-2023-00639
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00382903056095
• UDI-Public: (01)00382903056095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943575
• 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
• Report Date: 05/17/2023

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 Model Number: 305609
• Device Catalogue Number: 305609
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 06/01/2023
• 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