MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE IV CATHETER 20GA 1.16IN; INTRAVASCULAR CATHETER

Model Number	381234
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacture date: unknown.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 bd insyte¿ iv catheter 20ga 1.16in separated after placement.The following information was provided by the initial reporter: "iv catheter snapped off in artery 20g bd insyte cannula inserted to radial artery by anaesthetist in theatre patient returned to ward, patient started bleeding from cannula site.Upon inspection cannula appeared to have snapped.Tourniquet applied to stem bleeding patient returned to theatre to have removed, surgical incision and exploration of arm performed under general anesthetic to try and find other end of cannula.Snapped off piece of cannula found in bandages.Patient has numbness in hand post surgery.Sample available, but only the hub of the cannula".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/13/2020.H.6.Investigation: one sample was received by our quality team for evaluation.From the returned sample, a broken catheter was observed, confirming the customer experience.A device history record could not be evaluated as the lot number is unknown.The investigation found a sharp and flat cut on the broken edge of the catheter tubing.Based on the broken edge, no stretched phenomenon or elongation of the catheter tubing can be observed to indicate any issues with the tubing material that could have caused the breakage.This cut could have occurred during product application when the product was manipulated.If the broken catheter had occurred in the manufacturing process, the defected part would be rejected by the automated vision inspection system as the product does not have any lie distance.
Event or Problem Description
It was reported that bd insyte¿ iv catheter 20ga 1.16in separated after placement.The following information was provided by the initial reporter: "iv catheter snapped off in artery 20g bd insyte cannula inserted to radial artery by anaesthetist in theatre patient returned to ward, patient started bleeding from cannula site.Upon inspection cannula appeared to have snapped.Tourniquet applied to stem bleeding patient returned to theatre to have removed, surgical incision and exploration of arm performed under general anesthetic to try and find other end of cannula.Snapped off piece of cannula found in bandages.Patient has numbness in hand post surgery.Sample available, but only the hub of the cannula".

• Brand Name: BD INSYTE IV CATHETER 20GA 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 10305933
• Report Number: 9610048-2020-00110
• Device Sequence Number: 16358528
• Product Code: FOZ
• UDI-Device Identifier: 30382903812340
• UDI-Public: 30382903812340
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/24/2020

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: Other
• Device Model Number: 381234
• Device Catalogue Number: 381234
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 07/24/2020
• 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