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

Catalog Number	305786
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 luer-lok¿ syringe with detachable needle had foreign matter.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿this product has been using for quite a while in this unit.The users complain that there is oil in the plunger.The users understand that some oil is for lubrication.However, the oil now is too much comparing with the same product used before.".
Event or Problem Description
It was reported that bd luer-lok¿ syringe with detachable needle had foreign matter.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿this product has been using for quite a while in this unit.The users complain that there is oil in the plunger.The users understand that some oil is for lubrication.However, the oil now is too much comparing with the same product used before.".
Additional Manufacturer Narrative
H.6.Investigation: dhr for lot number 8274755 was reviewed and no qns or other events were related to the complaint stated by the customer.The samples received were visually inspected and it shows the defect of "too much oil in plunger" , the cause of this issue it is in the assembly and lubricate process with the supplier of the syringe, due that the syringe are received as a component in our process and then it is placed into the blister and then sealed and packed, the personnel that is placing the components on the multivac did not detect this defect during the packaging process with this condition we can confirm the issue stated by the customer with the samples received, after we inspected the retain samples we could also confirm the excess of oil(silicone) as the one showed on the sample received from the customer, we can assign this issue as a material supplier issue, this defect was not observed during the inspection process.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
• 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
• MDR Report Key: 8469499
• Report Number: 9610847-2019-00255
• Device Sequence Number: 1633937
• Product Code: FMI
• UDI-Device Identifier: 30382903057864
• UDI-Public: 30382903057864
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K161170
• 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): 06/10/2019

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: 09/30/2023
• Device Catalogue Number: 305786
• Device Lot Number: 8274755
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 06/10/2019
• 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