MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. PLUG LUER LOCK WHITE; LUER LOCK PLUG

Catalog Number 394080

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that an unspecified number of plug luer lock white experienced incorrect label information which was noted prior to use.The following information was provided by the initial reporter: incorrect information on the sticker applied for products to (b)(6).The sticker of the goods that came to us with the code 394080 is listed registration certificate ru 2008/01579 ot 31.12.10.Currently, we use the current ru and declaration to the stub, bd luer-lok plug, white / 394080/.

Manufacturer Narrative

This event has been identified as which is not considered a reportable event.The initial mdr, mfr report # 9610847-2020-00255 should therefore be disregarded.

Event Description

It was reported that an unspecified number of plug luer lock white experienced incorrect label information which was noted prior to use.The following information was provided by the initial reporter: incorrect information on the sticker applied for products to russia.The sticker of the goods that came to us with the code 394080 is listed registration certificate ru 2008/01579 ot 31.12.10.Currently, we use the current ru and declaration to the stub, bd luer-lok plug, white / 394080/.

• Brand Name: PLUG LUER LOCK WHITE
• Type of Device: LUER LOCK PLUG
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10434258
• MDR Text Key: 206877185
• Report Number: 9610847-2020-00255
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394080
• Device Lot Number: 0004300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other