MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD ECLIPSE¿ 5 ML BD LUER-LOK¿ SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305785
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2019
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.
Event or Problem Description
It was reported that bd eclipse¿ 5 ml bd luer-lok¿ syringe cap was loose.This was discovered before use.The following information was provided by the initial reporter: pink cap loose.
Additional Manufacturer Narrative
H.6.Investigation summary: one picture sample was provided for evaluation by our quality engineer team.Through examination of the picture, the pink cap was observed loose from the syringe.A device history record review was completed for provided lot number 8303774.The review did not reveal any detected abnormalities during the production process that could have contributed to this incident.A definite cause for this incident could not be determined.The physical sample would need to be provided to evaluate if the loose cap was related to handling or defective components.Our quality team will continue to monitor the production process for this defect and other emerging trends.
Event or Problem Description
It was reported that bd eclipse¿ 5 ml bd luer-lok¿ syringe cap was loose.This was discovered before use.The following information was provided by the initial reporter: pink cap loose.

• Brand Name: BD ECLIPSE¿ 5 ML BD LUER-LOK¿ SYRINGE
• 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: 9444180
• Report Number: 9610847-2019-00722
• Device Sequence Number: 16844020
• Product Code: FMI
• UDI-Device Identifier: 30382903057857
• UDI-Public: 30382903057857
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980987
• 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): 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/31/2023
• Device Model Number: 305785
• Device Catalogue Number: 305785
• Device Lot Number: 8303774
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/27/2020
• 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