MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE-W WINGED PNK 20GA X 1.88IN; INTRAVASCULAR CATHETER

Model Number	381337
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the insyte-w winged pnk 20ga x 1.88in, the catheter broke.The following information was provided by the initial reporter: catheter initially appearing to be kinked, line not sutured.Upon repositioning catheter and removing the securing strip over the hub, catheter noted to be completely broken off at the hub, with the catheter still in the vessel (pusatile blood flow noted).
Additional Manufacturer Narrative
Medical device expiration date: unknown.Initial reporter facility name: (b)(6) health sciences centre / (b)(6).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.
Additional Manufacturer Narrative
H6: investigation summary: one photo was received by our quality team for evaluation.From the photo, the catheter tubing was observed to be broken off near the nose of the adapter.A slanted cut was observed at the breakage point.A device history record could not be evaluated as the lot number is unknown.The assembly process was reviewed, the only station that is in contact with the catheter tubing is the rubber pads at the flaring station.Given the elastic nature of the rubber pads and that there are no sharp or hard edges on the pads, this station is unlikely to cause the observed slanted cut on the catheter tubing.The slanted cut on the catheter could occur during product application when the product was manipulated.Current quality controls include a daily outgoing functional test and a start of shift in-process functional test in place to check for catheter-to-adapter pull force.There is also a daily outgoing visual inspection and in-process visual inspection in place to check for catheter damage.The actual root cause cannot be established.
Event or Problem Description
It was reported that while using the insyte-w winged pnk 20ga x 1.88in, the catheter broke.The following information was provided by the initial reporter: catheter initially appearing to be kinked, line not sutured.Upon repositioning catheter and removing the securing strip over the hub, catheter noted to be completely broken off at the hub, with the catheter still in the vessel (pusatile blood flow noted).

• Brand Name: INSYTE-W WINGED PNK 20GA X 1.88IN
• 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 ; 8015296192
• MDR Report Key: 15491488
• Report Number: 8041187-2022-00562
• Device Sequence Number: 16608362
• Product Code: FOZ
• UDI-Device Identifier: 30382903813378
• UDI-Public: 30382903813378
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/08/2022

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: 381337
• Device Catalogue Number: 381337
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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