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	02/15/2019
Type of Reportable Event	Malfunction
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 that before use of the bd luer-lok syringe with detachable needle there was foreign body in the barrel.
Additional Manufacturer Narrative
Investigation: the picture received was inspected and it shows a foreign matter body in the barrel, after the review it can be seen that the body in the barrel looks like a part of ink stain.With this condition we can confirm the issue stated by the customer on the picture received, retain samples could not be reviewed due that no lot number was provided, we can assign this issue as a material defect, due that our process it is only packaging, we place the needle and the syringe on a blister and then it is sealed and packed, the defect stated by the customer it is confirmed.Review of dhr could not be performed due that lot number was not provided.We could not determine the root cause as a manufacturing defect, it can be assing it as a material, due that the foreign material was inside the syringe and this is provided by a supplier, our process it is only packaging, we place the needle and the syringe on a blister and then it is sealed and packed.
Event or Problem Description
It was reported that before use of the bd luer-lok¿ syringe with detachable needle there was foreign body in the barrel.

• 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: 8404119
• Report Number: 9610847-2019-00208
• Device Sequence Number: 16726291
• Product Code: FMI
• UDI-Device Identifier: 30382903057864
• UDI-Public: 30382903057864
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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 Catalogue Number: 305786
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 03/18/2019
• 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