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

Catalog Number	305785
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Pma/510(k)#: k980987(syringe); k161170 (needle).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 w/ detachable needle has missing scale markings.This was discovered before use.The following information was provided by the initial reporter: scale missing.
Additional Manufacturer Narrative
Investigation: a device history review was conducted for lot number 8274754.Material 305785 with lot number 8274754 was packaged on october 03, 2018, with order quantity of (b)(4).Dhr was reviewed for this lot number and there are no internal rejects related to the reported issue during this order.All relevant information during the dhr review shown that meet all established manufacturing criteria.One unpackaged sample was received and was detected in bad conditions, besides scale missing also the syringe was detected with damage neat to the bottom wings.After sample evaluation the reported issue can be confirmed since there is no scale at all on the syringe, therefore bd was able to confirm the customer¿s indicated failure mode but not manufacturing related, since the syringes are received and then load it in to the blister to be sealed after all components were loaded, therefore this is a material supplier issue, however a correct segregation should be performed by bd and personnel involved need to be awareness.
Event or Problem Description
It was reported that bd eclipse¿ 5-ml bd luer-lok syringe w/ detachable needle has missing scale markings.This was discovered before use.The following information was provided by the initial reporter: scale missing.

• Brand Name: BD ECLIPSE¿ 5-ML BD LUER-LOK SYRINGE W/ 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 ; MX
• MDR Report Key: 8935308
• Report Number: 9610847-2019-00539
• Device Sequence Number: 2099673
• Product Code: FMI
• UDI-Device Identifier: 30382903057857
• UDI-Public: 30382903057857
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H.10
• 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): 10/25/2019

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: 01/31/2023
• Device Catalogue Number: 305785
• Device Lot Number: 8274754
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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