MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 BLUE BLEND; STOP COCK

Catalog Number 394901

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

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.(b)(4).

Event Description

It was reported that the connecta plus3 blue blend experienced leakage.The following information was provided by the initial reporter: during anesthetic (propofol) infusion, leakage occurred from the connection between this product and non-bd¿s extension tubing.

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 9262741 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both picture and physical samples were returned for evaluation by our quality engineer team.The samples were visually inspected and functionally tested.All results were within specification with no signs of leakage observed.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this incident.

Event Description

It was reported that the connecta plus3 blue blend experienced leakage.The following information was provided by the initial reporter: during anesthetic (propofol) infusion, leakage occurred from the connection between this product and non-bd¿s extension tubing.

Manufacturer Narrative

H.6.Investigation: complaint coding was updated with imdrf coding.A device history record review was performed for provided lot number 9262741 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both picture and physical samples were returned for evaluation by our quality engineer team.The samples were visually inspected and functionally tested.All results were within specification with no signs of leakage observed.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this incident.

Event Description

It was reported that the connecta plus3 blue blend experienced leakage.The following information was provided by the initial reporter: during anesthetic (propofol) infusion, leakage occurred from the connection between this product and non-bd¿s extension tubing.

• Brand Name: CONNECTA PLUS3 BLUE BLEND
• Type of Device: STOP COCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 11098135
• MDR Text Key: 225286740
• Report Number: 9610847-2020-00438
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 394901
• Device Lot Number: 9262741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1