MAUDE Adverse Event Report: BECTON DICKINSON, S.A. NEEDLE ECLIPSE S/T 20X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305899
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 a needle eclipse s/t 20x1 rb had a broken safety mechanism during use.The following was reported by the initial reporter: "today, after administering the flu shot to a colleague, the cap broke off when "clicking" the cap over the needle.This happened very suddenly so i almost pricked myself to the used needle.I think it is important for you to know.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 10/30/2020.H.10.Investigation summary: a device history record review was performed for provided batch number 2006001 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, the physical sample was returned for evaluation by our quality engineer team.Through examination of the sample, the safety shield was observed broken at the ¿pivot¿ area ¿ the plastic apart that is directly assembled to the hub component.Each batch is inspected and tested for safety shield activation force, prior to release.All inspections and tests were found to be within specification for this batch.Based on the investigation results, a cause related to the manufacturing process could not be determined for this incident.It is possible that then handling of the product impacted the safety shield.We can ensure that the probability of finding this kind of defect is an isolated issue and any recurrence is really unlikely in our products since review dhr showed no indication of the alleged defect and since this is the first time this lot is reported for this defect, no actions are required at this time.H3 other text : see h.10.
Event or Problem Description
It was reported that a needle eclipse s/t 20x1 rb had a broken safety mechanism during use.The following was reported by the initial reporter: "today, after administering the flu shot to a colleague, the cap broke off when "clicking" the cap over the needle.This happened very suddenly so i almost pricked myself to the used needle.I think it is important for you to know.

• Brand Name: NEEDLE ECLIPSE S/T 20X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• MDR Report Key: 10909602
• Report Number: 3002682307-2020-00379
• Device Sequence Number: 19584976
• Product Code: FMI
• UDI-Device Identifier: 50382903058995
• UDI-Public: 50382903058995
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 305899
• Device Catalogue Number: 305899
• Device Lot Number: 2006001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1