MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381212
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 28 bd insyte¿ iv catheters were found to be damaged/frayed during use.The following information was provided by the initial reporter: "partial box of 50 lnsyte catheters returned their customer reported that they are not feeding correctly.The catheters sent back would not feed into the vein after venipucture.All staff placing catheters experienced this, not just one.A different lot number would feed fine, this took place over several weeks (we do surgery tues/thurs mornings)at first it was dismissed as a bad vein day/technique but other sizes or lot numbers would work just fine.I did look at a few of the catheter ends under the microscope, they appeared frayed? unfortunately, several patients had several legs shaved to aid in eventual placement of a catheter.".
Event or Problem Description
It was reported that 28 bd insyte¿ iv catheters were found to be damaged/frayed during use.The following information was provided by the initial reporter: "partial box of 50 lnsyte catheters returned their customer reported that they are not feeding correctly.The catheters sent back would not feed into the vein after venipucture.All staff placing catheters experienced this, not just one.A different lot number would feed fine, this took place over several weeks (we do surgery tues/thurs mornings)at first it was dismissed as a bad vein day/technique but other sizes or lot numbers would work just fine.I did look at a few of the catheter ends under the microscope, they appeared frayed? unfortunately, several patients had several legs shaved to aid in eventual placement of a catheter.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 10-apr-2023 h6: investigation summary our quality engineer inspected the 28 representative samples submitted for evaluation.The reported issue of catheter defective / damaged was not confirmed upon inspection and testing of the samples.Analysis of the sample showed that there were no abnormalities or defects present on the samples.The samples were also functionally tested for cannula penetration and all samples performed as designed.Bd cannot determine a root cause for the event reported since the failure was not confirmed during the sample evaluations.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: BD INSYTE¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16635631
• Report Number: 8041187-2023-00126
• Device Sequence Number: 7423302
• Product Code: FOZ
• UDI-Device Identifier: 00382903812127
• UDI-Public: 00382903812127
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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
• Operator of Device: Other
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 381212
• Device Lot Number: 0224296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown