MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 25X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305759
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle eclipse 25x1 rb label content was missing the following information was provided by the initial reporter: it was reported by the customer that the our staff noticed a miss label on (b)(4) boxes of needles.Please see the pic provided.Verbatim: rcc received a complaint via email.Email(s) attached.Cat# of product being complained: bd305761 description of product: needle eclipse 25gx1in use ll sp=pk 100ea/pk 12pk/ca.Lot or s/n: (b)(6).Complaint category: labelling issue reportable: no.Incident date: (b)(6) 2024.Hospital complaint reference #: details of complaint (reported issue): our staff noticed a miss label on(b)(4) boxes of needles.Please see the pic provided.I believe only part of the case was impacted.Complaint noticed: prior to use.Problem frequency: 1st time.Customer exposure: patient injury: no.Has health canada been informed? no.Qty affected: (b)(4).Samples available? no.Is customer requesting an rga?: no.
Event or Problem Description
Material#: 305761, lot#: 0115011.It was reported by the customer that the our staff noticed a miss label on four boxes of needles.Please see the pic provided.Verbatim: rcc received a complaint via email.Email(s) attached.Cat# of product being complained: bd305761.Description of product: needle eclipse 25gx1in use ll sp=pk 100ea/pk 12pk/ca.Lot or s/n: (b)(6).Complaint category: labelling issue.Reportable: no.Incident date: 02 feb 2024.Hospital complaint reference #: details of complaint (reported issue): our staff noticed a miss label on four boxes of needles.Please see the pic provided.I believe only part of the case was impacted.Complaint noticed: prior to use.Problem frequency: 1st time.Customer exposure:.Patient injury: no.Has health canada been informed? no.Qty affected: 1 ca.Samples available? no.Is customer requesting an rga?: no.Return qty: follow up: 02/15/2024: there is a sample, but we have yet to receive the packing slip that i can see.None were used on patients.
Additional Manufacturer Narrative
During dhr review, it was observed that on production date 07 may 2020, inspection form, at 23:10hr, 4pcs of wrong top web (catalog 305761) and at 01:30hr (08 may 2020), 2pcs of wrong top web (catalog 305761) was pasted.Sa was initiated on incorrect label content (wrong top web).Capa was also initiated to address on this nonconformance.Below is the probable cause identified: the production technician did not verify the top web information during inspection.There is no detection of the top web by vision system.There is no designated area for return top web material.Below action in the capa# 2835276 had been implemented to address the nonconformance.Re-training on the inspection procedure was conducted to the eclipse team.Inspection form, was updated to include inspection for pre-printed top web.Installed vision system to combo2 packaging line to detect wrong top web and validation was completed.Designated area for return top web material had been identified and documented.

• Brand Name: BD NEEDLE ECLIPSE 25X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 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: 18809295
• Report Number: 2243072-2024-00230
• Device Sequence Number: 7169085
• Product Code: FMI
• UDI-Device Identifier: 30382903057598
• UDI-Public: (01)30382903057598
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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 Expiration Date: 04/30/2025
• Device Catalogue Number: 305759
• Device Lot Number: 0115011
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown