MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 14G X 1.75IN (2.1 X 45 MM) INSYTE AUTOGUARD; INTRAVASCULAR CATHETER

Catalog Number	381467
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the 14g x 1.75in (2.1 x 45 mm) insyte autoguard experienced a needle that would not retract during use.The following information was provided by the initial reporter: nurse cannulated patient and attempted to deploy safety on cannula by depressing the button.Needle did not retract and hub stayed attached to cannula.
Additional Manufacturer Narrative
H.6.Investigation summary: received 2 undamaged packages of product 381467 from lot 8064954.One package (unit 1) was opened and contained only the protective needle cover.The second package (unit 2) was sealed and contained an unused representative unit fully intact.A review of the device history record revealed no irregularities during the manufacture of the reported lot.Visual/microscopic evaluation: unit 1: there was no damage observed to the needle cover.Unit 2: there was no physical damage to any area of the unit (components).Functional test (needle retraction) for unit 2: according to pps-001 version g revision 13 needle retraction time is considered slow if it exceeds 1 second to retract.In order to test for needle retraction, the clinical instructions are followed.Removed the needle cover from unit 2 and rotated the catheter, releasing the tip adhesion.Depressed the activation button, at which time no resistance was met and the needle fully retracted.Based on the observation and testing conducted on the unused representative unit provided for this incident the defect failure to decouple (needle retraction failure) was not be confirmed.Conclusion(s): not determined ¿ the root cause cannot be determined for an unconfirmed defect.
Event or Problem Description
It was reported that the 14g x 1.75in (2.1 x 45 mm) insyte autoguard experienced a needle that would not retract during use.The following information was provided by the initial reporter: nurse cannulated patient and attempted to deploy safety on cannula by depressing the button.Needle did not retract and hub stayed attached to cannula.

• Brand Name: 14G X 1.75IN (2.1 X 45 MM) INSYTE AUTOGUARD
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9355342
• Report Number: 1710034-2019-01237
• Device Sequence Number: 10885445
• Product Code: FOZ
• UDI-Device Identifier: 30382903814672
• UDI-Public: 30382903814672
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K952861
• 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): 01/09/2020

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 381467
• Device Lot Number: 8064954
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/09/2020
• 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