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

Catalog Number	381233
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 catheter has burrs and is difficult to retract with a bd insyte¿ iv catheter.The following information was provided by the company reporter: it was reported that the catheter has been burring and not functioning properly.It was clarified that the needle would give resistance and catch when pulling it back.The following information was provided by the initial reporter: health professional noted that when pulling the stylet back before insertion it is creating resistance and catching on the hub part which makes it not function properly.This has happened several times recently (no specific dates could be given) with lot # 8300598.No patient or user harm or medical intervention, only additional pokes and a change to a different manufacturer's catheter.Same issues now occurring with 22g, could not provide product info.Samples for 20g available, although he was not sure about 22g.The technicians have had a lot of issues with burring and not functioning properly.They actually had to stop using them and switch to different catheters.
Event or Problem Description
It was reported that catheter has burrs and is difficult to retract with a bd insyte¿ iv catheter.The following information was provided by the company reporter: it was reported that the catheter has been burring and not functioning properly.It was clarified that the needle would give resistance and catch when pulling it back.The following information was provided by the initial reporter: health professional noted that when pulling the stylet back before insertion it is creating resistance and catching on the hub part which makes it not function properly.This has happened several times recently (no specific dates could be given) with lot # 8300598.No patient or user harm or medical intervention, only additional pokes and a change to a different manufacturer's catheter.Same issues now occurring with 22g, could not provide product info.Samples for 20g available, although he was not sure about 22g.The technicians have had a lot of issues with burring and not functioning properly.They actually had to stop using them and switch to different catheters.
Additional Manufacturer Narrative
H.6.Investigation summary: one actual sample and eleven representative samples were received by our quality team for evaluation.Visual inspection was performed on the catheter before and after the needle was retracted with no abnormalities identified; therefore the reported failure cannot be verified.A device history record review found no non- conformances associated with this issue during production of this batch.Based on the quality teams investigation, the root cause of this incident cannot be determined.H3 other text : see section h.10.

• Brand Name: BD INSYTE¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9310710
• Report Number: 8041187-2019-00913
• Device Sequence Number: 19593827
• Product Code: FOZ
• UDI-Device Identifier: 30382903812333
• UDI-Public: 30382903812333
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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: 10/31/2023
• Device Catalogue Number: 381233
• Device Lot Number: 8300598
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 11/25/2019
• 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