MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA WHT 360DEG TB 25CM; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 394926

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Underdose (2542); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that connect a wht 360deg tb 25cm tubing ruptured.This occurred on 3 occasions.The following information was provided by the initial reporter: medication used with the product? omnipaque.Leakage? yes, large amount of contrast agent on patient, examination table and floor.Impact on a patient? contrast examination on ct - patient has had less contrast than necessary during the examination.Samples? unused sample can be sent for investigation.We have had the problem with some stopcocks.The tubing burst open during injection at the level of the stopcock.

Manufacturer Narrative

H.6.Investigation: a complaint of tubing bursting open was received from the customer.41 samples were returned for investigation.Through testing, the customer complaint was verified.A device history record review was completed by our quality engineer team for provided lot number 0183678.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.The root cause for this defect was determined to be a misalignment issue during the assembly process of the tube and the fitting.This is the first complaint for tubing defective/damaged on material 394926 & batch 0183678.

Event Description

It was reported that connecta wht 360deg tb 25cm tubing ruptured.This occurred on 3 occasions.The following information was provided by the initial reporter: medication used with the product? omnipaque.Leakage? yes, large amount of contrast agent on patient, examination table and floor.Impact on a patient? contrast examination on ct - patient has had less contrast than necessary during the examination.Samples? unused sample can be sent for investigation.We have had the problem with some stopcocks.The tubing burst open during injection at the level of the stopcock.

• Brand Name: CONNECTA WHT 360DEG TB 25CM
• 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 ; MX
• MDR Report Key: 11382512
• MDR Text Key: 266420554
• Report Number: 9610847-2021-00084
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 394926
• Device Lot Number: 0183678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1