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

Model Number	305785
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980987 (syringe), pma / 510(k)#: k161170 (needle).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the stopper in the bd luer-lok¿ syringe with bd eclipse¿ detachable needle was found distorted before use.The following information was provided by the initial reporter: "stopper distorted.".
Additional Manufacturer Narrative
H.6.Investigation summary: to aid in the investigation of this incident, one physical sample was returned for evaluation by our quality engineer team.Through examination of the sample, the stopper was observed distorted.It has been determined that this incident is related to an defect in the raw materials provided by the supplier.As a lot number was unavailable for this incident, further information regarding the provided syringe materials could not be obtained.As this product is no longer produced on the same manufacturing line, further action has not been determined necessary at this time.Our quality team will closely monitor the production process for signs of this potential defect and any emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported that the stopper in the bd luer-lok¿ syringe with bd eclipse¿ detachable needle was found distorted before use.The following information was provided by the initial reporter: "stopper distorted".

• Brand Name: BD LUER-LOK SYRINGE WITH BD ECLIPSE 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: 10418294
• Report Number: 9610847-2020-00246
• Device Sequence Number: 14301451
• 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): 09/09/2020

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 Model Number: 305785
• Device Catalogue Number: 305785
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/10/2020
• 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