MAUDE Adverse Event Report: BECTON DICKINSON BD SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB; SYRINGE

Catalog Number	305786
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
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 syr 10ml ll w/ndl eclipse 22x1-1/2 rb unit packaging was damaged the following information was provided by the initial reporter: the packaging was not developed and the syringe was damaged.
Additional Manufacturer Narrative
Damaged package based on device history record review, no abnormality was observed during the production of the affected batches.From the returned sample the package was opened.There is sealing transfer on the bottom web indicating no sealing related defects.Furthermore, there is no punctured top and bottom web observed.Current control there is a visual inspection on damaged package at the qa outgoing inspection and visual inspection on damaged package at the combo packaging in-process inspection.Therefore, actual root cause cannot be determined.The complaint trend will continued to be tracked and monitored.Barrel / flange damaged based on device history record review, no abnormality was observed during the production of the affected batches.The eclipse primary packaging line was reviewed.There is no machine contact on a large barrel surface which could press on the barrel to create the damage.There is a small contact with the barrel surface during pick and place of barrel, however, the pick and place gripper is made of rubber and via the suction motion which unlikely to crack.The syringe assembly line was reviewed.Different machine sections were reviewed to match the potential area which could cause the damage barrel.Probable cause could be due to leak test lower tooling screw got loosen, thereby causing barrel is unable to sit properly when the part is transferring to exercise dial pocket.This has eventually led to part jammed and cracked barrel.Action had been taken to add in the kahle assembly yearly preventive maintenance checklist to check the condition of the leak test tooling screw.This batch produced is before the action implementation date.
Event or Problem Description
The packaging was not developed and the syringe was damaged.

• Brand Name: BD SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB
• Common Device Name: SYRINGE
• 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: 18895938
• Report Number: 2243072-2024-00279
• Device Sequence Number: 12309159
• Product Code: FMI
• UDI-Device Identifier: 30382903057864
• UDI-Public: (01)30382903057864
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: 08/31/2026
• Device Catalogue Number: 305786
• Device Lot Number: 1238922
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown