MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number 309703

Device Problem Missing Information (4053)

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

Event Date 10/16/2023

Event Type  malfunction  

Event Description

It was reported that the bd luer-lok syringe label content was missing.The following information was provided by the initial reporter: "we are having issues with the labels peeling off the 5 ml and 10 ml syringes." sorry for the delay, we seemed to have missed your previous email.Sample status? available/not available- not available.Patient status?- not applicable.Date of event?- ongoing.

Manufacturer Narrative

The date received by manufacturer has been used for this field.Other lot number includes 3150597.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Other device manufacture date is 06/16/2023.

Manufacturer Narrative

A device history record review was completed by our quality engineer team for provided material number 385108 and lot number 309703.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, the photo provided is not applicable to the complaint of a 5ml product code, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.

Event Description

Material#: 309703 batch#: 3118878, 3150597, 3096912.It was reported by customer that customer reported having issues with the labels peeling off the 5 ml and 10 ml syringes.I have attached a photo of a 10 ml syringe with the peeling label.I unfortunately do not have any example of the 5 ml to show you.Verbatim: hello, sorry for the delay, we seemed to have missed your previous email.1.Sample status? available/not available- not available.2.Patient status?- not applicable.3.Date of event?- ongoing.4.Please provide batch number?- all.5.Please provide material number?- 309702, 309703, 309605.It was reported by customer that customer reported having issues with the labels peeling off the 5 ml and 10 ml syringes.I have attached a photo of a 10 ml syringe with the peeling label.I unfortunately do not have any example of the 5 ml to show you.

• Brand Name: BD LUER-LOK
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales CT ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18097868
• MDR Text Key: 327701559
• Report Number: 1213809-2023-01237
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903097037
• UDI-Public: (01)30382903097037
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309703
• Device Lot Number: 3118878
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1