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	Eye Injury (1845)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.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.
Event or Problem Description
It was reported when engaging the safety shield of a bd luer-lok¿ syringe with detachable needle blood went into the users eyes.Customer reported no medical interventions were provided.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacturer: no.This supplemental mdr also corrects the event description: it was reported when engaging the safety shield of a bd luer-lok syringe with detachable needle, that blood went into the user's eyes.Medical intervention is unknown.
Event or Problem Description
It was reported when engaging the safety shield of a bd luer-lok syringe with detachable needle, that blood went into the user's eyes.Medical intervention is unknown.
Event or Problem Description
It was reported when engaging the safety shield of a bd luer-lok¿ syringe with detachable needle blood went into the users eyes.Customer reported no medical interventions were provided.
Additional Manufacturer Narrative
H.6.No samples sent/received of syr 10ml ll w/ndl eclipse 22x1-1/2 rb catalog 305786 with lot number 7356447.According to issue stated by customer ¿blood exposure to the user¿s eyes¿.No sample was received.Review of dhr could not be performed due that the lot number provided was not found on the lot number database and could not match with the one provided on the claim.According to the statement of complaint we cannot confirm the issue stated by the customer and we cannot assign it as a manufacturing defect.We could not determine the root cause and cannot confirm the issue stated by the customer due that no samples were provided and the lot number was not found as a lot number produced by bd nogales.

• 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: 7694777
• Report Number: 9610847-2018-00207
• Device Sequence Number: 848128
• Product Code: FMI
• UDI-Device Identifier: 00382903057863
• UDI-Public: 00382903057863
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2018

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 Catalogue Number: 305786
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 06/22/2018; 06/22/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/09/2018; 09/20/2018
• 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