MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA¿ SAFETY IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	386801
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device expiration date: unknown.Initial reporter phone #: unknown.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use the safety mechanism failed, which resulted in exposed needle with a bd cathena¿ safety iv catheter.The following information was provided by the initial reporter: it was reported that the safety mechanism failed to activate resulting in an exposed needle.Per initial complaint: lot number unknown at this point but manager is trying to locate from internal "sims" report.Trauma patient came into the er from a car accident, was communicated that patient had excellent vascular access, attempted to insert an 18g cathena in upper right arm or hand (he does not recall location of insertion), proceeded to insert the iv, pushed the green hub forward and pulled back on the stylet when the needle became exposed and the safety mechanism failed to activate resulting in an exposed needle.
Event or Problem Description
It was reported that during use the safety mechanism failed, which resulted in exposed needle with a bd cathena¿ safety iv catheter.The following information was provided by the initial reporter: it was reported that the safety mechanism failed to activate resulting in an exposed needle.Per initital complaint: lot number unknown at this point but manager is trying to locate from internal "sims" report.Trauma patient came into the er from a car accident, was communicated that patient had excellent vascular access, attempted to insert an 18g cathena in upper right arm or hand (he does not recall location of insertion), proceeded to insert the iv, pushed the green hub forward and pulled back on the stylet when the needle became exposed and the safety mechanism failed to activate resulting in an exposed needle.
Additional Manufacturer Narrative
The following fields have been updated with additional information: "multiple lot numbers: there were multiple possible lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 8144026.D.4.Medical device expiration date: 2021-06-30.H.4.Device manufacture date: 2018-05-24.D.4.Medical device lot #: 8060125.D.4.Medical device expiration date: 2021-03-31.H.4.Device manufacture date: 2018-03-01." h3 other text : see h.10.
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the returned photo but could not clearly identify the reported defect.A device history record review showed no non-conformances associated with this issue during the production of the possible batches reported.Since no samples were returned we were unable to determine a definitive root cause for this report.H3 other text : see h.10.
Event or Problem Description
It was reported that during use the safety mechanism failed, which resulted in exposed needle with a bd cathena¿ safety iv catheter.The following information was provided by the initial reporter: it was reported that the safety mechanism failed to activate resulting in an exposed needle.Per initital complaint: lot number unknown at this point but manager is trying to locate from internal "sims" report.Trauma patient came into the er from a car accident, was communicated that patient had excellent vascular access, attempted to insert an 18g cathena in upper right arm or hand (he does not recall location of insertion), proceeded to insert the iv, pushed the green hub forward and pulled back on the stylet when the needle became exposed and the safety mechanism failed to activate resulting in an exposed needle.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8776630
• Report Number: 2243072-2019-01368
• Device Sequence Number: 1977189
• Product Code: FOZ
• UDI-Device Identifier: 00382903868018
• UDI-Public: 00382903868018
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• 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,Followup
• Report Date (Section B): 08/23/2019

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: Other
• Device Catalogue Number: 386801
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 06/25/2019; 06/25/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/12/2019; 08/23/2019
• 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