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

Catalog Number	381334
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been received that makes this a reportable event.2019-09-27.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 before use of the bd insyte-w winged pnk 20ga x 1.16in the needle was twisted through the catheter requiring the use of another catheter.The following information was provided by the initial reporter, translated from (b)(6) to english: when intravenous catheterization, the tip of the mandrel being twisted, it was impossible to infuse the patient.The clinical consequences are: none.However, necessity to use another medical device.
Additional Manufacturer Narrative
Investigation: one photo and three samples were received for the 20 ga insyte by our quality team for investigation.Upon visual inspection of the sample received, it was observed that the needle pierced through the catheter, therefore the failure can be confirmed.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation the root cause of this incident cannot be determined as there were no non-conformances noted during the manufacturing process.This failure may occur during the product application when the product is manipulated.
Event or Problem Description
It was reported that before use of the bd insyte-w winged pnk 20ga x 1.16in the needle was twisted through the catheter requiring the use of another catheter.The following information was provided by the initial reporter, translated from french to english: when intravenous catheterization, the tip of the mandrel being twisted, it was impossible to infuse the patient.The clinical consequences are: none.However, necessity to use another medical device.

• Brand Name: BD 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: 9146157
• Report Number: 8041187-2019-00781
• Device Sequence Number: 2183814
• 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
• 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): 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 381334
• Device Lot Number: 8018411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other