MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA; CONNECTA STOPCOCKS

Catalog Number 394601

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

It was reported that bd connecta plus3 white pegs is leaking.The following information was provided by the initial reporter: "three-way stopcock is leaking.The nurse noticed that blood was leaking.When rinsing the three-way stopcock with nacl 0.9%, it was also noticed that liquid was leaking out even though the stopcock was closed.".

Manufacturer Narrative

(b)(4).Initial mdr.A follow up will be submitted if additional information becomes available.

Manufacturer Narrative

Our quality engineer inspected the 2 photos and 1 physical sample submitted for evaluation.The reported issue of leakage was confirmed upon inspection of the sample and photos.Analysis of the sample photos did not confirm the reported defect since the defect mentioned was not observed.However, examination of the physical sample found that there was a crack at one of the ports of the sample, which is likely the cause of the leakage reported.Bd determined that the cause of the failure was likely associated to use error.The appearance of these cracks is typical for cracks that can occur when the product has been used together with lubrication solution or infusion with high ph-value.These solutions can release internal stress in the product.If excessive force is used when connecting and using the product for more than 24 hours, this may cause the material to crack.It is possible for improper handling of the device to result in the reported defect.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.

Manufacturer Narrative

Our quality engineer inspected the 2 photos and 1 physical sample submitted for evaluation.The reported issue of leakage was confirmed upon inspection of the sample and photos.Analysis of the sample photos did not confirm the reported defect since the defect mentioned was not observed.However, examination of the physical sample found that there was a crack at one of the ports of the sample, which is likely the cause of the leakage reported.Bd determined that the cause of the failure was likely associated to use error.The appearance of these cracks is typical for cracks that can occur when the product has been used together with lubrication solution or infusion with high ph-value.These solutions can release internal stress in the product.If excessive force is used when connecting and using the product for more than 24 hours, this may cause the material to crack.It is possible for improper handling of the device to result in the reported defect.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.

Event Description

Three-way stopcock is leaking.Copoy paste protocol: three-way stopcock is leaking.The nurse noticed that blood was leaking.When rinsing the three-way stopcock with nacl 0.9%, it was also noticed that liquid was leaking out even though the stopcock was closed.(b)(6)2023 - additional information provided by the bd rep: 1.The 3wh is used for various applications (short infusions but also direct iv administration with the syringe).2.Citation protocol "the nursing noticed that blood was leaking".This means that the 3wh was leaking and in the closed state (all legs are closed), that there was nevertheless a backflow.This should not happen! this would also mean, if a medication was given before, over one of the thighs, the blood would be contaminated with this chemical.- however, this is unclear and i could not get an answer to this.3.Quotation protocol "when rinsing the 3wh with nacl 0.9%, it was also noticed that liquid leaked out despite the tap being closed".That is, exactly what i described as "must not happen" was described here by the user.Thus, the user himself could see that the stopcock was not fulfilling its function.

• Brand Name: BD CONNECTA
• Type of Device: CONNECTA STOPCOCKS
• 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: 17906752
• MDR Text Key: 326057112
• Report Number: 9610847-2023-00278
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K974083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394601
• Device Lot Number: 3013510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1