MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305786
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter additional phone#: (b)(6).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 syr 10ml ll w/ndl eclipse 22x1-1/2 rb was damaged.The following information was provided by the initial reporter: when end-user open package for use, found the bd eclipse needle angled / tilted / bent - not straight.And the syringes plunger rubber is defected / damaged / improperly fixed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-12-10.H6: investigation summary: a device history record review was completed for provided lot number 9246157.The review revealed that this lot was manufactured according to the approved manufacturing procedures and specifications, with no non-conformances at the time of production.To aid in the investigation of this issue, one physical sample and picture samples were returned for evaluation by our quality engineer team.Through evaluation of the physical sample, the needle component was found straight and not bent.The needle was re-assembled on the syringe several times to test for improper attachment; however, the reported failure could not duplicated as the needle went on properly and straight each time.If the needle was improperly attached to the syringe luer, it would result in a crooked attachment.H3 other text : see h10.
Event or Problem Description
It was reported that syr 10ml ll w/ndl eclipse 22x1-1/2 rb was damaged.The following information was provided by the initial reporter: when end-user open package for use, found the bd eclipse needle angled / tilted / bent - not straight.And the syringes plunger rubber is defected / damaged / improperly fixed.

• Brand Name: SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 11089878
• Report Number: 9610847-2020-00434
• Device Sequence Number: 11690168
• Product Code: FMI
• UDI-Device Identifier: 00382903057863
• UDI-Public: 00382903057863
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/09/2021

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: 04/30/2024
• Device Catalogue Number: 305786
• Device Lot Number: 9246157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1