MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD LUER-LOK, BD ECLIPSE; NEEDLE

Catalog Number	305780
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd luer-lok, bd eclipse had a scale marking issue.The following information was provided by the initial reporter: we received the following complaint regarding item#305780 syringe/ndl, eclipse safety 1c c thin wall 25gx5/8" (50/bx) for a total of one case.It was reported by the customer that they received a number of bd eclipse 1ml 5/8¿ 25g syringes ((b)(4)) that had worn off markings and could not be used.I have attached pictures of a few of the impacted syringes where you can see the markings missing.Unfortunately the patient was unable to provide a lot/expiration date for these syringes as they had placed the packaging in their sharps container.Please see attached pictures.The items were purchased on (b)(4).The customer is requesting replacement of the case.You will find the point of contact for the customer is listed below.Please advise if anything further is needed.Additional information provided on 03/04/2024: 1.Please confirm the number of product having the issues.Approximately 12 syringes reported.2.Did the event involve an urgent/life threatening medical situation? no, administering medication and had extra syringes on hand until replacement arrived.3.Any sample available for investigation? no, patient discarded all immediately into sharps container before contacting us.4.Date of event: original 1/12/24, additional 2 syringes discovered by same patient on 2/15/24 (could have been from same original dispense).
Additional Manufacturer Narrative
D.3.Franklin lakes has been listed as the manufacturer.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The 1ml syringe part is purchased from bd canaan however batch number is unavailable.The packaging line was reviewed and there is no area that would contribute to the ¿scale marking issue¿.Bd canaan had been notified of this complaint for investigation.Current control there is a visual inspection on barrel print defect at the qa outgoing inspection.
Event or Problem Description
Material#: 305780, batch#: unknown.It was reported by the customer that they received a number of bd eclipse 1ml 5/8¿ 25g syringes (ref 305780) that had worn off markings and could not be used.I have attached pictures of a few of the impacted syringes where you can see the markings missing.Unfortunately the patient was unable to provide a lot/expiration date for these syringes as they had placed the packaging in their sharps container.Verbatim: rcc received a complaint via email.Email(s) attached.We received the following complaint regarding item#305780 syringe/ndl, eclipse safety 1c c thin wall 25gx5/8" (50/bx) for a total of one case.Per the customer, " they stated that they received a number of bd eclipse 1ml 5/8¿ 25g syringes (ref 305780) that had worn off markings and could not be used.I have attached pictures of a few of the impacted syringes where you can see the markings missing.Unfortunately the patient was unable to provide a lot/expiration date for these syringes as they had placed the packaging in their sharps container." please see attached pictures.The items were purchased on po#(b)(4).The customer is requesting replacement of the case.You will find the point of contact for the customer is listed below.Please advise if anything further is needed.Comments on 04/03/2024, 1.Please confirm the number of product having the issues.Approximately 12 syringes reported.2.Did the event involve an urgent/life threatening medical situation? no, administering medication and had extra syringes on hand until replacement arrived.3.Any sample available for investigation? no, patient discarded all immediately into sharps container before contacting us.4.Date of event: original 1/12/24, additional 2 syringes discovered by same patient on (b)(4) 2024 (could have been from same original dispense).

• Brand Name: BD LUER-LOK, BD ECLIPSE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18959444
• Report Number: 2243072-2024-00430
• Device Sequence Number: 18482895
• Product Code: FMI
• UDI-Device Identifier: 30382903057802
• UDI-Public: (01)30382903057802
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• 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): 05/13/2024

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: Other
• Device Catalogue Number: 305780
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown