MAUDE Adverse Event Report: BECTON DICKINSON AS SYR PSD MICROBORE; INTRAVENOUS EXTENSION TUBING SET

Catalog Number	10014914
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material#: 10014914.It was reported by customer that leaking fluids.Upon infusion, rn noticed some leaking from gub connection between nad and pressure disc tubing.Verbatim#: rcc received a complaint via email.Email(s) attached please see the below cif / product complaint for item 10014914 on stocking po (b)(4).Please provide next steps on credit or return / credit.Record number : (b)(4).Initial reporter : (b)(6).Sales rep : (b)(6).Description as reported : leaking fluids.Upon infusion, rn noticed some leaking from gub connection between nad and pressure disc tubing.This is multiple items being reported as failed splitting cifs for each vendor - items are a pressure disc tubing, cardiac filter, microclave external reference number : (b)(4).Account number : (b)(6).Account name : (b)(6).Product code : al10014914.Additional information: what is the date of event? (b)(6) 2024.Describe any patient harm, injury, complication or negative outcome that occurred because of the event.The event occurred while in use with patient but no serious injury or harm was done.Delay in care.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? yes, we have the item(s) ready to be returned for evaluation.(b)(6).
Additional Manufacturer Narrative
The customer reported leaking at pressure disc, and returned one used sample of material 10014914, lot unknown.The set was visually examined for defects and abnormalities.No defects or abnormalities were observed.The set was infused with water from the included syringe, and the set infused normally without any leaks.The set was clamped and pressurized at 10 psi, but still, no leaks were observed.The customer complaint was not able to be replicated.The root cause is unknown without a replicated failure.A device history record review could not be performed on material 10014914 because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• Brand Name: AS SYR PSD MICROBORE
• Common Device Name: INTRAVENOUS EXTENSION TUBING SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18969010
• Report Number: 9616066-2024-00460
• Device Sequence Number: 12404803
• Product Code: FPA
• UDI-Device Identifier: 10885403233906
• UDI-Public: (01)10885403233906
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 10014914
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown