MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 G X 1.00 IN. (0.9 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381523

Device Problems Fail-Safe Design Failure (1222); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary (b)(4) mdr, part #: 381523, lot #: 7122821, complaint: needle retraction failure.Event description: the customer is having issues with this lot as is continuing to break with the staff.Lot analysis: device/batch history record review: yes.Reason: dhr¿s are available for reviews as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable.This incident is mdr.Findings: lot 7122821- the lot was built on (b)(4) from may 9, 2017 through may 15, 2017.Per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.Set-up and in process samples (including but not limited to) for damaged component (grip, button, spring, hub), needle retraction by button activation and adhesive overfilled/drip as well as periodic cleaning/alignment of the glue grippers were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.Qn / sap database review: no.Reason: qn/sap database review is not required for level a investigations per (b)(4).The peura (end user risk analysis): yes.Reason: the peura is required for all mdr reportable investigations.Findings: rm5835 rev 11 version i was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Visual analysis: observations and testing: received a total of (b)(4) units from lot number 7122821.All units were received within sealed and inside their respective dispensers, their components were intact.Visual/microscopic examination: no mechanical/physical damage was observed to the spring, needle hub or grip.There were no missing components or evidence of glue on the buttons or hubs.Functional test (needle retraction): the needle covers were removed, manually rotated the catheter tips 360 degrees, the catheter tubing did not ¿candy canned¿.The white buttons were depressed and the needles did retract meeting no resistance.Retraction was successful.Test description: visual/microscopic, method no: n/a, results: see observations and testing; functional test, n/a, see observations and testing.Investigation samples(s) meet manufacturing specifications: yes.No mechanical/physical damage was observed and the units demonstrated a successful retraction when tested in the laboratory environment.Investigation conclusion: conclusions: the defect of needle retraction failure as stated in the event description could not be confirmed with the representative units returned for evaluation and testing.Did the evaluation confirm the customer¿s experience with the bd product? no; the defect of needle retraction failure that the customer experienced was not confirmed with the units received for evaluation and testing.Were we able to reproduce the customer's experience with the bd product? no; reproduction of the failure that the customer experienced could not be achieved with the evaluation and testing performed on the units received in the laboratory environment.Was the device used for treatment or diagnosis? treatment.Root cause description: relationship of device to the reported incident: indeterminate.Comment: the returned representative units did not display any adverse characteristics that would contribute to the defect the customer experienced.The defect described in the event description could not be confirmed or replicated with the returned representative units.The actual unit described in the incident report was not returned for evaluation.

Event Description

It was reported that a bd 22 g x 1.00 in.(0.9 mm x 25 mm) bd insyte¿ autoguard¿ shielded iv catheter malfunctioned during use, as the needle would not retract into the safety device.The nurse had to call for assistance from another nurse to come over and ¿use additional hands¿ to get the device to finally retract.On at least one occasion, they had to remove the device all together and use a new one.There was no report of injury or medical intervention needed.

• Brand Name: 22 G X 1.00 IN. (0.9 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7017648
• MDR Text Key: 92780107
• Report Number: 1710034-2017-00326
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903815235
• UDI-Public: 30382903815235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 381523
• Device Lot Number: 7122821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other