MAUDE Adverse Event Report: BECTON DICKINSON CAP TIP SYR LL/LS STER LF PP BLUE SINGLE; CONTAINER, LIQUID MEDICATION, GRADUATED

Catalog Number 305819

Device Problem Expiration Date Error (2528)

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

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f27 ¿ no patient involvement.Device problem code: a210101 - expiration date error.

Event Description

Material#: 305819 batch: 3227156.It was reported by customer that the customer reports they were made aware on 10/20/23, of expiration date on the label.The label does not match certificate shows a 2 month difference, quantity of 5 cases have been impacted, 2000 per cases.Distributor: thermo fisher.The customer also requests a replacement.Additional information: 1.Sample status-physical sample available or not available we have the material in our warehouse; it is currently quarantined and we seek to return the material back to vendor.3.Ptient status not applicable; the material has not been released for use in manufacture of our medical devices due to the expiration date discrepancy between the label and coa.4.Please supply additional patient information: a.Age : n/a.B.Gender: n/a.C.Weight ethnicity, and/or race? n/a.5.Was there any adverse event or serious injury reported? no.6.What procedure was being performed? we were performing inspection of the received material in to our manufacturing facility when we discovered the expiration date discrepancy.7.Any adverse event or serious injury reported to patient or healthcare professional? n/a material has not been used for any product yet.8.Was there a delay of, or change in, the course of treatment due to the event? n/a.

Manufacturer Narrative

(b)(4) follow up.It was reported the expiration date on the label does not match certificate.As a sample was not returned, a sample investigation could not be completed.A device history record review was completed for provided material number (b)(4), lot 3227156.The review revealed there was a similar issue identified during the production of this lot.A related quality notification was issued, and all processes and final inspections complied with specification requirements.This defect could occur if the system pulled the information from the original planned dates of the production order and was not updated to the correct information.A revised certificate has been issued.Based on the investigation the symptom reported by the customer is confirmed.

Event Description

Material#: 305819; batch: 3227156.It was reported by customer that the customer reports they were made aware on 10/20/23, of expiration date on the label.The label does not match certificate shows a 2 month difference, quantity of 5 cases have been impacted, 2000 per cases.Distributor: thermo fisher.The customer also requests a replacement.Verbatim: no additional information received.Rcc received a complaint via phone.Pir attached.The customer reports they were made aware on 10/20/23, of expiration date on the label.The label does not match certificate shows a 2 month difference, quantity of 5 cases have been impacted, 2000 per cases.Distributor: thermo fisher.The customer also requests a replacement.Ref# (b)(4).Lot# 3227156.

• Brand Name: CAP TIP SYR LL/LS STER LF PP BLUE SINGLE
• Type of Device: CONTAINER, LIQUID MEDICATION, GRADUATED
• 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: 18022378
• MDR Text Key: 327734064
• Report Number: 1911916-2023-00807
• Device Sequence Number: 1
• Product Code: KYW
• UDI-Device Identifier: 00382903058198
• UDI-Public: (01)00382903058198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305819
• Device Lot Number: 3227156
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1