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	Leak/Splash (1354)
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 stopper was deformed.This was discovered before use.The following information was provided by the initial reporter: distorted stopper.
Event or Problem Description
It was reported that bd eclipse¿ 5-ml bd luer-lok syringe w/ detachable needle stopper was deformed.This was discovered before use.The following information was provided by the initial reporter: distorted stopper.
Additional Manufacturer Narrative
H.6.Investigation: a device history review was conducted for lot number: 8274754.The material 305785 was packaged on october 03, 2018, with order quantity of 100,860 ea.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.Raw material (syringe) part number: 301027: according to the device history record two lost number from part number: 301027 were used for the manufacturing of this lot.8025817.8204626.After sample evaluation the reported failure mode can be confirmed since it was observed the stopper distorted 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 loading 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 nogales before loading the syringes and after sealing with the 100% visual inspection.H3 other text : see h.10.

• 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: 8935416
• Report Number: 9610847-2019-00540
• Device Sequence Number: 513674
• 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