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

Model Number	381234
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 3 bd insyte¿ iv catheters broke from their hubs after placing them in the patients.The following information was provided by the initial reporter: "plastic cannulas broke whilst cannulating patients.".
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: 11/16/2021.H.6.Investigation: four representative samples with sealed packaging were received by our quality team for evaluation.The samples were first subjected to visual inspection to check for catheter damage, and then further subjected to the catheter pull test.All four samples met the product specification.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.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 is any broken catheter occurred in the manufacturing process, the defect part would be rejected by the automated vision inspection system as the product will fail the lie distance.The nonconformance could have occurred out of the manufacturing facility during product application.As all representative samples passed the visual inspection and catheter pull test, and no actual samples were returned, a root cause could not be established.H3 other text : see h.10.
Event or Problem Description
It was reported that 3 bd insyte¿ iv catheters broke from their hubs after placing them in the patients.The following information was provided by the initial reporter: "plastic cannulas broke whilst cannulating patients.".

• 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: 12870581
• Report Number: 8041187-2021-01004
• Device Sequence Number: 17037095
• Product Code: FOZ
• UDI-Device Identifier: 30382903812340
• UDI-Public: 30382903812340
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/13/2021

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 Expiration Date: 02/28/2026
• Device Model Number: 381234
• Device Catalogue Number: 381234
• Device Lot Number: 1049153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2021
• 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