MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA PLUS3 10CM WHITE; STOPCOCK, I.V. SET

Catalog Number 394995

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd connecta plus3 10cm white had a loose component the following information was provided by the initial reporter: quantity affected: several are affected and the service has isolated the entire batch the fitting came loose during injection.We would like to exchange it.The offending device is available from the pharmacy for examination.Please note that the sample is contaminated.The rest of the unused batch is also available (203 fittings).Please send us a pre-stamped box or envelope to send the offending sample or contact us to arrange for a courier to come and collect it.We remain at your disposal for any further information.

Manufacturer Narrative

Our quality engineer inspected the photo and physical samples submitted for evaluation.The reported issue of loose component - no leak was confirmed upon inspection of the samples and photo.Analysis of the sample and photo showed that there were loose components of the samples returned.Bd determined that the cause of the failure was manufacturing related.A change has been made to our manufacturing process to prevent the occurrences of failures for this product line.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.

Event Description

1.Could you confirm the lot/serial number of the defective product? (b)(6).2.Could you indicate the date of the event? 24/12/2023.3.Please confirm the number of products affected: (b)(4).4.Have there been any consequences for patients (serious injury, medical intervention, change in treatment needed)? there were no consequences impacting the patient.The various breakages that have occurred on this type of device have just caused a loss of time to replace a new extension and inject with a lower pressure.5.Please also let us know the full pick-up address, contact name and number, service name, floor number and any other additional details (pick up at reception, goods in the yard, etc.) and we will schedule a sample pick-up request for you using the tnt carrier.You can pick up the offending devices from monday to friday from 8 a.M.To 2:30 p.M.At the (b)(6).If there is a problem at the time of pick-up, you can contact me on (b)(6).Carriers will be able to pick up the boxes at the reception docks.Could you please explain in detail "the fitting has come loose during injection" indicating whether the connecting device has come loose or whether it is a connection problem with another set/product? ans: the luer lock connector came loose from its tubing during the injection procedure for an injectable drug (scanner service).Could you please provide a photo of the product connector and circle/underline the location where the "fitting came off"? follow up 3: on (b)(6) 2024.Could you please send us the photo of the product connector and circle/underline the place where the "connector came off" as our system does not support this photo file extension.Can you confirm whether the product is contaminated with blood or cytotoxic drugs? customer response received on (b)(6) 2024.The drug injected at the time of the problem was a contrast agent.There was no cytotoxic contamination.The care teams do not remember whether there was any blood contamination.Several cases of "unsoldering" occurred with this batch.However, the radio handlers rinsed the tubing before sending it to the pharmacy.

• Brand Name: BD CONNECTA PLUS3 10CM WHITE
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18696663
• MDR Text Key: 335300359
• Report Number: 9610847-2024-00026
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394995
• Device Lot Number: 3227534
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1