MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AG BC GLOBAL; PERIPHERAL IV CATHETERS

Model Number (01)00382903810123

Device Problem Retraction Problem (1536)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte ag bc global needle did not retract properly.The following information was provided by the initial reporter, translated from japanese to english: it was reported that needle does not retract properly when needle stow button is pressed after puncture.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E contact phone and email information not provided.

Manufacturer Narrative

Investigation results: the complaint of improper needle retraction could not be confirmed from the samples that were provided for investigation.39 representative insyte autoguard samples and 2 used insyte autoguard samples were provided for investigation.The needles on the used samples were fully retracted.Visual inspection did not discover any damage to the barrel, coils, or button that may indicate any possible needle retraction failures.No dry adhesive was discovered.The two units were then tested by placing the cannula back into initial position and activating the button.Both units retracted successfully.20 of the sealed units were selected for needle retraction testing.All 20 units retracted successfully.No damages or evidence of potential defects were discovered.The reported defect could not be confirmed.Six photographs were also provided for investigation, which showed two needles fully retracted.A functional test of the returned samples revealed no manufacturing defects or operational problems.Although the photographs, returned samples, and manufacturing records do not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.

Event Description

No additional information.

• Brand Name: BD INSYTE AG BC GLOBAL
• Type of Device: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18918932
• MDR Text Key: 337854293
• Report Number: 1710034-2024-00191
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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 Model Number: (01)00382903810123
• Device Catalogue Number: 38101201
• Device Lot Number: 3121182
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/16/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1