MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA PLUS3 WHITE PEGS; STOPCOCK

Catalog Number 394601

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

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

Event Date 02/12/2023

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.

Event Description

It was reported that 3 of the bd connecta plus3 white pegs were cracked causing leakage.The following information was provided by the initial reporter, translated from german to english: leakage 3-way taps: approx.3 hours after connection the patient noticed that the shirt is wet.Small cracks in the plastic were partially visible at the luer connection.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 28-mar-2023.H6: investigation summary our quality engineer inspected the 3 samples submitted for evaluation.The reported issue of component damage ¿ leak was confirmed upon inspection and testing of the samples.Analysis of the sample showed that there are cracks in the port housing.The samples underwent leakage testing and they experienced leakage at the b port.A review of the manufacturing process was performed and there are no processes which could cause the damages observed on the returned samples.The most probable root cause to the failure was use error.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.Production records were reviewed, and this batch met our manufacturing product specification requirements.

Event Description

It was reported that 3 of the bd connecta plus3 white pegs were cracked causing leakage.The following information was provided by the initial reporter, translated from german to english: leakage 3-way taps --> approx.3 hours after connection the patient noticed that the shirt is wet.Small cracks in the plastic were partially visible at the luer connection.

• Brand Name: BD CONNECTA PLUS3 WHITE PEGS
• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16524323
• MDR Text Key: 311404784
• Report Number: 9610847-2023-00053
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394601
• Device Lot Number: 2203901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• 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