MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE-W WINGED PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Model Number	381334
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that insyte-w winged pnk 20ga x 1.16in catheter broke.The following information was provided by the initial reporter: at the end of the patient's infusion placement, the needle of the mandrel remained in the catheter uncoupled from the plastic.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-02-16.H6: investigation summary: forty-four representative samples were received by our quality team for evaluation.The samples were subjected to visual inspection and no needle pierced through catheter was observed on the samples.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
It was reported that insyte-w winged pnk 20ga x 1.16in catheter broke.The following information was provided by the initial reporter: at the end of the patient's infusion placement, the needle of the mandrel remained in the catheter uncoupled from the plastic.

• Brand Name: INSYTE-W WINGED PNK 20GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11263828
• Report Number: 8041187-2021-00061
• Device Sequence Number: 16927022
• Product Code: FOZ
• UDI-Device Identifier: 30382903813347
• UDI-Public: 30382903813347
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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: 08/31/2025
• Device Model Number: 381334
• Device Catalogue Number: 381334
• Device Lot Number: 0233519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1