MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE-N WINGED YEL 24GA X 0.56IN; INTRAVASCULAR CATHETER

Model Number	381311
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that a insyte-n winged yel 24ga x 0.56in had the needle through the catheter and a split catheter during use.The following was reported by the initial reporter: "we have been informed of a malfunction with the (b)(4) reference device.The service informs us that for several months now, 50% of this material is unusable when opening.The bevel of the needle is oriented on the wrong side and when the caregivers readjust the positioning of the bevel, the catheter splits or is pierced.All lots are affected by this problem.The affected device is at your disposal.There were no patient consequences.As stated in the report, these incidents are frequent (50% of the equipment is unusable).No incriminated device has been kept, this incident occurring once out of two times.However, unused devices of the same reference were set aside.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-12-10.H6: investigation summary: one representative and one actual sample was received by our quality team for evaluation.From the returned samples, no needle bevel incorrect orientation was observed.However, needle through catheter was observed on the returned actual sample.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 following controls have been put in place to prevent and detect the needle being pierced through catheter from occurring: the vision system camera is not out of focus when capturing the defect by using various metal blocks for different gauges to prevent the vision assembly from dropping under its weight and the catheter is aligned to one side using vacuum to aid the insertion of the cannula thus reducing the likelihood of this nonperformance from occurring.A daily challenge of the vision system is performed and visual inspection is performed during outgoing inspection.This incident has been added to our database of reported incidents.
Event or Problem Description
It was reported that a insyte-n winged yel 24ga x 0.56in had the needle through the catheter and a split catheter during use.The following was reported by the initial reporter: "we have been informed of a malfunction with the 381311 reference device.The service informs us that for several months now, 50% of this material is unusable when opening.The bevel of the needle is oriented on the wrong side and when the caregivers readjust the positioning of the bevel, the catheter splits or is pierced.All lots are affected by this problem.The affected device is at your disposal.There were no patient consequences.As stated in the report, these incidents are frequent (50% of the equipment is unusable).No incriminated device has been kept, this incident occurring once out of two times.However, unused devices of the same reference were set aside.".

• Brand Name: INSYTE-N WINGED YEL 24GA X 0.56IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10805669
• Report Number: 8041187-2020-00710
• Device Sequence Number: 11712330
• Product Code: FOZ
• UDI-Device Identifier: 30382903813118
• UDI-Public: 30382903813118
• 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,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2020

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: Health Professional
• Device Model Number: 381311
• Device Catalogue Number: 381311
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/24/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1