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

Catalog Number	10014918
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
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 # 10014918 lot # (10)23115155 it was reported by customer that they got notified about a patient incident report regarding a pinhole found in tubing.There were no punctures or damage noted to the packaging.There were zero issues when priming the line.The reporting pharmacist states after the medication was attached to the patient the blood began to back up in the line and exposed the small hole, stating, ¿it may have been a crack, but to the naked eye, we couldn¿t tell.The only evidence was the blood dripping from a particular spot on the tubing.¿ the medication was disconnected and remade.New tubing was attached and the medication was administered without an issue.Rcc received a complaint via email.Email(s) attached.I was provided your info to let you know about an incident with a hole in iv tubing here at (b)(6),.I was notified about a patient incident report regarding a pinhole found in tubing shown in the attached pictures.There were no punctures or damage noted to the packaging.There were zero issues when priming the line.The reporting pharmacist states after the medication was attached to the patient the blood began to back up in the line and exposed the small hole, stating, ¿it may have been a crack, but to the naked eye, we couldn¿t tell.The only evidence was the blood dripping from a particular spot on the tubing.¿ the medication was disconnected and remade.New tubing was attached and the medication was administered without an issue.
Additional Manufacturer Narrative
It was reported by customer that they got notified about a patient incident report regarding a pinhole found in tubing.Two photos of item 10014918 were received for quality evaluation.One photo shows the packaging label of the product, and the second photo shows the product with what appears to be blood leaking out of the tubing.Further inspection of the second photo shows that there is leakage from the tubing, however, it cannot be determined where the leakage is coming from in the photo.The customer complaint of leakage was verified.Although leakage can be verified, due to the lack of a physical sample the root cause for the issue indicated in the submitted photos could not be determined.A device history record review for model 10014918 lot number 23115155 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 08nov2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: AS SYR PSD LOW SORB MICROBORE
• Common Device Name: INTRAVENOUS EXTENSION TUBING SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18969537
• Report Number: 9616066-2024-00465
• Device Sequence Number: 6213198
• Product Code: FPA
• UDI-Device Identifier: 10885403233944
• UDI-Public: (01)10885403233944
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 06/27/2024

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: 10014918
• Device Lot Number: 23115155
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown