MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE GN 18GA X 1.88IN; INTRAVASCULAR CATHETER

Model Number	381247
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2020
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.(b)(4).
Event or Problem Description
It was reported that the insyte gn 18ga x 1.88in needle wouldn't retract during use.The following information was provided by the initial reporter: "after inserting, catheter kinking and can¿t draw out needle".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-10-20.H6: investigation summary one sample in open packaging was received by our quality team for evaluation.From the sample, the catheter was observed to be kinked and burred on the tip.Therefore, the team was able to confirm the customer experience.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.The manufacturing process was reviewed.The investigation shows that the tipper machine was the only possible area which the catheter might get kinked.A double adapter might be the possible cause of the catheter kink.A simulation was performed to duplicate the defect.The duplicated sample was observed to have a similar catheter kink to the complaint sample, however it shows an incomplete tip.The simulated sample was assembled at the machine and was observed to have the needle pierced through the catheter.The lie distance vision and tip spear vision in place for this process to detect and reject the needle pierced through catheter.As the sample was returned in an open packaging, the nonconformance was likely caused by product manipulation.H3 other text : see h.10.
Event or Problem Description
It was reported that the insyte gn 18ga x 1.88in needle wouldn't retract during use.The following information was provided by the initial reporter: "after inserting, catheter kinking and can¿t draw out needle".

• Brand Name: INSYTE GN 18GA X 1.88IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10752539
• Report Number: 8041187-2020-00699
• Device Sequence Number: 3800142
• Product Code: FOZ
• UDI-Device Identifier: 30382903812470
• UDI-Public: 30382903812470
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/03/2020

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: 10/31/2023
• Device Model Number: 381247
• Device Catalogue Number: 381247
• Device Lot Number: 8300600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1