MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 21X1-1/2 RB TW; SYRINGE

Catalog Number	305765
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
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 needle eclipse 21x1-1/2 rb tw package damaged/ defective.It was reported by customer that one needle pouch was detected with a tear in the paper tyvek backing.Verbatim: rcc received a complaint via email.During packaging operations, one needle pouch was detected with a tear in the paper tyvek backing.The tear was miniscule and observed by the aql inspector.
Additional Manufacturer Narrative
The reported issue of packaging damaged/ defective was confirmed upon inspection of the samples.Analysis of the samples showed a white line mark on the package on one unit.This unit was subjected to a bubble leak test and passed with no abnormalities noted.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.The packaging process was reviewed.The probable root cause is that the pocket is deformed due to material shrinkage.The shallow pocket might cause the product to protrude into the top web paper, which caused the white line mark.Shallow pockets are formed when there are long machine stoppages due to production technicians needing to attend to machine related issues or trouble shooting.A corrective action was completed to revise the program to include a line unload cycle for prevention of shallow pockets.The affected lot was produced before action implementation.
Event or Problem Description
Material # 305765.Batch # 2343741.It was reported by customer that one needle pouch was detected with a tear in the paper tyvek backing.Verbatim: rcc received a complaint via email.During packaging operations, one needle pouch was detected with a tear in the paper tyvek backing.The tear was miniscule and observed by the aql inspector.

• Brand Name: BD NEEDLE ECLIPSE 21X1-1/2 RB TW
• 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: 19751961
• Report Number: 2243072-2024-00801
• Device Sequence Number: 9016313
• Product Code: FMI
• UDI-Device Identifier: 00382903057658
• UDI-Public: (01)00382903057658
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: 305765
• Device Lot Number: 2343741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown