MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 WHITE BLEND W/O NUT OEM; STOPCOCK

Catalog Number 395180

Device Problem Leak/Splash (1354)

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

Event Date 12/11/2020

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that the connecta plus3 white blend w/o nut oem leaked saline from a crack.The following information was provided by the initial reporter, translated from (b)(6) to english: "this is a report about leakage of saline due to a cracked connecta (the one connected to c35) of 515570-zat.".

Manufacturer Narrative

Investigation summary: to aid in the investigation of this incident, the affected sample was returned to bd for evaluation by our quality engineer team.Through examination of the sample, the stopcock housing component was observed damaged.The appearance of cracks typically result when the product has been used together with a lubricant solution or an infusion with a high ph value.These solutions can stress the formulation of the product.If excessive force is used when connecting the product or if the product is used for over twenty-four hours, cracking may occur.Per the instructions for use, the user should avoid over tightening the connection, check connections regularly, change the stopcock every seventy-two hours, or change the stopcock every twenty-four hours depending on the type of infusate used.At this time, further action has not been determined necessary at the manufacturing facility.

Event Description

It was reported that the connecta plus3 white blend w/o nut oem leaked saline from a crack.The following information was provided by the initial reporter, translated from japanese to english: "this is a report about leakage of saline due to a cracked connecta (the one connected to c35) of 515570-zat.".

• Brand Name: CONNECTA PLUS3 WHITE BLEND W/O NUT OEM
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 11143637
• MDR Text Key: 226041858
• Report Number: 9610847-2021-00005
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1