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	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the needle eclipse s/t 20x1 rb separated from the syringe during an intramuscular injection of "haldol decanoas".This complaint was created to capture the 4th of 4 related incidents.The following information was provided by the initial reporter, translated from french to english: "our problem occurs when injecting haldol decanoas (oily product): the needle comes loose from the syringe.It is likely that this happens because the needle is not held in place when the plunger of the syringe is pressed." "this problem frequently occurs when performing an intramuscular (im) injection and even more so if the product is oily and/or viscous.Overpressure causes the needle and syringe to dissociate.And for having practiced this type of injection it happens with any im.So i don't think this is related to bd dms in particular." "another factor promoting dissociation is the use of luer slip syringes rather than luer lock.".
Event or Problem Description
It was reported that the needle eclipse s/t 20x1 rb separated from the syringe during an intramuscular injection of "haldol decanoas".This complaint was created to capture the 4th of 4 related incidents.The following information was provided by the initial reporter, translated from french to english: "our problem occurs when injecting haldol decanoas (oily product): the needle comes loose from the syringe.It is likely that this happens because the needle is not held in place when the plunger of the syringe is pressed."."this problem frequently occurs when performing an intramuscular (im) injection and even more so if the product is oily and/or viscous.Overpressure causes the needle and syringe to dissociate.And for having practiced this type of injection it happens with any im.So i don't think this is related to bd dms in particular."."another factor promoting dissociation is the use of luer slip syringes rather than luer lock.".
Additional Manufacturer Narrative
H6: investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.A device history review could not be completed as no batch number was provided.

• 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: 11089402
• Report Number: 3002682307-2020-00434
• Device Sequence Number: 2666903
• Product Code: FMI
• UDI-Device Identifier: 50382903058995
• UDI-Public: 50382903058995
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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 Model Number: 305899
• Device Catalogue Number: 305899
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1