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

Model Number	381244
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that part of the bd insyte¿ iv catheter separated from the hub when removing the dressing.The following information was provided by the initial reporter: "staff advise this iv luer was found leaking when it was to be redressed.On removing the dressing in place the hub and approx.6mm of the cannula came with the dressing.The remainder of the cannula was luckily retrieved quickly, and the measure of the device length indicates the full device has been retrieved.Iv had been in situ only 12 hours having been placed in (r) hand in theatre, prior to an elective procedure.Antibiotics, crystalloid iv fluids and phenylephrine were infused through the cannula.Batch details are not available as the device fault was found when patient back in the department post op.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/1/2021.H.6.Investigation: one photo and one sample were received by our quality team for evaluation.From the photo, the catheter was broken in a short distance away from the adapter.The sample was subjected to visual inspection to check for catheter damage.It was observed that the catheter was broken in a short distance away from the adapter, with a clean cut at the separation point.A device history record could not be evaluated as the lot number is unknown.A manufacturing review was performed at the flaring and swage depth measuring station and there are no possible contact points which could cause any damage to the catheter.There is also an automated vision system at the assembly machine whereby if there a broken catheter occurred in the manufacturing process, the defective part would be rejected by the automated vision inspection system as the product will fail the lie distance.This nonconformance could have occurred out of the manufacturing facility during product application.
Event or Problem Description
It was reported that part of the bd insyte¿ iv catheter separated from the hub when removing the dressing.The following information was provided by the initial reporter: "staff advise this iv luer was found leaking when it was to be redressed.On removing the dressing in place the hub and approx.6mm of the cannula came with the dressing.The remainder of the cannula was luckily retrieved quickly, and the measure of the device length indicates the full device has been retrieved.Iv had been in situ only 12 hours having been placed in r) hand in theatre, prior to an elective procedure.Antibiotics, crystalloid iv fluids and phenylephrine were infused through the cannula.Batch details are not available as the device fault was found when patient back in the department post op.".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12790852
• Report Number: 8041187-2021-00965
• Device Sequence Number: 19838197
• Product Code: FOZ
• UDI-Device Identifier: 30382903812449
• UDI-Public: 30382903812449
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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 Model Number: 381244
• Device Catalogue Number: 381244
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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