MAUDE Adverse Event Report: BECTON DICKINSON AS LVP 20D LOW SORB 2SS 0.2M CV; INTRAVENOUS EXTENSION TUBING SET

Catalog Number 11532269

Device Problem Leak/Splash (1354)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

Materials: 11532269 batch#: 23115345 it was reported by the customer that leaking blood and chemo thank you in advance for your follow-up on this product concern ailin chen purchasing clerk, clinical sourcing team clinical support department.: chc complaint reference (b)(4) hospital complaint reference (b)(4) customer (hospital) name: (b)(6) health customer address: (b)(6) contact name: (b)(6) phone: (b)(6) e-mail: (b)(6) correspondence language: english cat# of product being complained: al11532269 description of product: set check valve 0.2mic 2nf 87/6in 2pc male l/l 20ea/ca lot or s/n: (b)(6) complaint category: leaking reportable: no incident date: on (b)(6) 2024 hospital complaint reference (b)(4).Details of complaint (reported issue): from: (b)(6) [phsa] sent: monday, on (b)(6) 2024 11:41 amto: gmb-can-chc-complaints cc: (b)(6) [vch] ;(b)(6) [phsa] ; data entry sc data (b)(6) please follow up with (b)(6) for the product concern outlined below within 3 business days; and advise of any special shipping instructions for pick up, courier or discarding of product.Please investigate and follow up with a written report from your quality assurance as to your findings and resolutions.Product concern ticket number: (b)(4) date of incident: on (b)(6) 2024 hospital: (b)(6) hospital : leukemia/bmt product: bd alaris pump infusion set 0.2 micron filter w/ back check valve low sorbing vmid: 11532269 lot number: (10)23115345 product expiry date: 21-nov-2026 number of defective product(s): 1 is sample available: yes concern description: self disconnect - leaking blood and chemo thank you in advance for your follow-up on this product concern ailin chen purchasing clerk, clinical sourcing team clinical support department sample available supplier please send customer sample return instructions customer indicated that they wish to be provided with the final results of this investigation.** complaint noticed: during / after use problem frequency: 1st time customer exposure: patient injury: no has health canada been informed? no qty affected: (b)(4) ea samples available? yes is customer requesting an rga?: no return qty: qty samples: (b)(4) ea.

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.

Manufacturer Narrative

It was reported that there was a leak.One partial sample model 11532269, lot 23115345 was returned for investigation.The set was examined for defects and abnormalities.The only part of the set that was returned was the tubing after the most distal smartsite.No defects or abnormalities were observed.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, this issue could not be replicated in the production process and no opportunities were found in the manufacturing of the model and affected component.Therefore, the root cause is unknown.A device history record review for model 11532269 lot number 23115345 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28nov2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

No additional info.

• Brand Name: AS LVP 20D LOW SORB 2SS 0.2M CV
• Type of Device: 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: 18969009
• MDR Text Key: 338663345
• Report Number: 9616066-2024-00458
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232343
• UDI-Public: (01)10885403232343
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K022209
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11532269
• Device Lot Number: 23115345
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1