MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305763
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that needle eclipse 22x1-1/2 rb package was damaged.This was discovered before use.The following information was provided by the initial reporter: before use, the user found that the seal were opened.
Event or Problem Description
It was reported that needle eclipse 22x1-1/2 rb package was damaged.This was discovered before use.The following information was provided by the initial reporter: before use, the user found that the seal were opened.
Additional Manufacturer Narrative
Investigation: one photo was received by our quality team for evaluation.From the photo, it was observed that the sealing was open at the side of the unit package.There was also an indication of sealing transfer to the bottom web which indicates that the sealing process was completed.Therefore, the team was able to confirm the customer experience.A device history record review found no abnormalities during the production of this batch.The sealing process parameters were reviewed and were within specifications.Based on the photo, there is an indication of sealing transfer to the bottom web indicating the sealing process was completed.The root cause due to the manufacturing process could not be established.

• Brand Name: NEEDLE ECLIPSE 22X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10723097
• Report Number: 8041187-2020-00687
• Device Sequence Number: 1114516
• Product Code: FMI
• UDI-Device Identifier: 30382903057635
• UDI-Public: 30382903057635
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 09/30/2023
• Device Model Number: 305763
• Device Catalogue Number: 305763
• Device Lot Number: 8264055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other