MAUDE Adverse Event Report: BECTON DICKINSON PRI SET W/MANIFOLD & EXT. SET - 42511E; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	42511E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #: 42511e.Batch#: unknown.It was reported by customer that the tubing comes apart easily and because of this, patients have bled because it wasn't caught in time.Ref number: 42511e.No serial number given at the time of the call.Please send ack letter and closure letter.Verbatim: rcc received a complaint via phone.Pir attached.Customer states that the tubing comes apart easily and because of this, patients have bled because it wasn't caught in time.Ref number: 42511e.No serial number given at the time of the call.Please send ack letter and closure letter.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of sets come apart easily could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 42511e because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.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.

• Brand Name: PRI SET W/MANIFOLD & EXT. SET - 42511E
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 19584454
• Report Number: 9616066-2024-00916
• Device Sequence Number: 12582734
• Product Code: FPA
• UDI-Device Identifier: 10885403235412
• UDI-Public: (01)10885403235412
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 10/14/2024

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: 42511E
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown