MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM WITH SMALL BORE EXTENSION SET, FIXED NUT; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 385102

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd q-syte¿ luer access split septum with small bore extension set, fixed nut packaging contained different product.Noticed before use.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that the bd q-syte luer access split septum with small bore extension set, fixed nut packaging contained different product.Noticed before use.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

The device history report for lot number 7116695 was reviewed, no related abnormalities were found.Material number (b)(4) for lot 7116695 was manufactured on 05/27/2017.This is the first instance of this failure mode with this lot number.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections additionally the photograph was provided for the purpose of aiding our quality engingeer's investigation.The photo displayed both material numbers (b)(4) in a single box.Review of these two material number determined that the materials are not manufactured on the production line, and visual inspection processes are in place to eliminate the occurrence of this failure mode.Unfortunately without being able to reference the lot number of the superfluous material our engineers could not determine the root cause of this issue.Based on investigation results to date, root cause for manufacturing process cannot be determined.

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 manufacture: no.

Event Description

It was reported that the bd q-syte luer access split septum with small bore extension set, fixed nut packaging contained different product.Noticed before use.There was no report of exposure, injury, or medical intervention noted.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM WITH SMALL BORE EXTENSION SET, FIXED NUT
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7704416
• MDR Text Key: 114701106
• Report Number: 9610847-2018-00215
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851028
• UDI-Public: 30382903851028
• Combination Product (y/n): N
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2018

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
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 385102
• Device Lot Number: 7116695
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 06/28/2018; 06/28/2018
• Supplement Dates FDA Received: 08/15/2018; 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other