MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD NEEDLE ECLIPSE 25X1 RB; ECLIPSE NEEDLE

Catalog Number 305837

Device Problem Break (1069)

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

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that the bd needle eclipse 25x1 rb needle was broken.The following information was provided by the initial reporter: "the tip of the needle broke." injuries or adverse event: no.Medline reference #: (b)(4).Item: 305837.Quantity affected: 2 bx.Serial/lot number: (b)(6).Po #: (b)(4).Are any samples available for return? yes reported issue per customer: customer michaela emailed to report the tip of the needle broke.Pictures attached.Replacement requested.Lot 2305839.Customer disposition request: replacement.

• Brand Name: BD NEEDLE ECLIPSE 25X1 RB
• Type of Device: ECLIPSE NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18700419
• MDR Text Key: 335949475
• Report Number: 1920898-2024-00059
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2024

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: 305837
• Device Lot Number: 2305839
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1