MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X5/8 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number 305122

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6) : initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a041001 - material puncture / hole and a0504 - leak / splash patient problem code: f27 ¿ no patient involvement the actual date of event is unknown.The date received by manufacturer was entered into the date of event field.

Event Description

Mat#: 305122, batch#: 3083970.It was reported by customer that liquid leaking out of the hub, holes in the hub.Verbatim: rcc received complaint via email.Email(s) attached.Good afternoon ¿ please find complaint attached reported to xxxx - liquid leaking out of the hub ¿ holes in the hub.

Manufacturer Narrative

(b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 305122 and lot number 3083970.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

Event Description

No additional information received material #: 305122 batch#: 3083970.It was reported by customer that liquid leaking out of the hub, holes in the hub.Verbatim: rcc received complaint via email.Email(s) attached.Good afternoon ¿ please find complaint attached reported to xxxx - liquid leaking out of the hub ¿ holes in the hub.

• Brand Name: NEEDLE 25X5/8 RB
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17984448
• MDR Text Key: 326277831
• Report Number: 1911916-2023-00794
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903051220
• UDI-Public: (01)30382903051220
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021475
• 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,Followup
• Report Date: 10/28/2023

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: Health Professional
• Device Catalogue Number: 305122
• Device Lot Number: 3083970
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 10/28/2023
• Supplement Dates FDA Received: 10/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1