MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 21X1-1/2 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305765
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that needle eclipse 21x1-1/2 rb tw had a safety mechanism failure.The following information was provided by the initial reporter: material no:305765 batch no: 0090373.  it was reported that during packaging, a five pack of 21g needles was found to be missing the complete needle in one packet and the needle was missing the safety shield in a second packet.
Event or Problem Description
It was reported that needle eclipse 21x1-1/2 rb tw had a safety mechanism failure.The following information was provided by the initial reporter: material no:305765 batch no: 0090373   it was reported that during packaging, a five pack of 21g needles was found to be missing the complete needle in one packet and the needle was missing the safety shield in a second packet.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/30/2021.H.6.Investigation: one photo and five samples were received by our quality team for evaluation.From the photo, one product was observed to be missing from the unit package and one product was missing a safety shield.The samples were subjected to visual inspection.One eclipse product was observed tot be missing from the unit blister and one eclipse product was observed to be missing the safety shield and only the pivot rod at the eclipse hub.A device history record review found no non-conformances associated with this issue during production of this batch.The primary packaging process was reviewed.After the safety shield was inserted to the eclipse hub hook, it could have been broken during exercising and then dropped off during movement to subsequent process.As the broken piece of the safety shield was unavailable, the actual root cause could not be determined.There is a vision system to detect missing components and empty blister.Upon detection by vision, the production technician is required to remove product with missing components and ensure all empty blister pocket/product with missing components are topped up with good parts.The vision system was verified and able to detect product with missing components and empty blister pocket.Therefore, it is likely that the production technician had failed to remove product with missing components and topped up with good parts for empty blister pocket / product with missing components.At the secondary packaging process, there is a checkweigher to detect for correct count.The checkweigher was verified and able to reject shelf carton that are underweight.However, there is a possibility that due to carton weight variation, this nonconformance was not detected.

• Brand Name: NEEDLE ECLIPSE 21X1-1/2 RB TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11822966
• Report Number: 8041187-2021-00408
• Device Sequence Number: 4414994
• Product Code: FMI
• UDI-Device Identifier: 00382903057658
• UDI-Public: 00382903057658
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: Other
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 305765
• Device Lot Number: 0090373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1