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

Catalog Number 381423

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

Unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

This complaint is mdr reportable.It was reported that a 22 g x 1.00 in.Bd insyte¿ auto guard¿ shielded iv catheter failed to function properly during/post use.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: the corrective action statement is approved/authorized and final review of the complaint will be conducted by designated complaint handling unit.Investigation completed by: (b)(6), pr #: (b)(4), cr#: (b)(4), type: mdr with sample.Part #: 381423, lot #: 7146918, complaint: needle retraction slow.Customer verbatim: not sure if anyone has reported an issue with this, but one of the adult infusion nurses reported she started an iv on a patient and when she pressed the button to retract the metal needle from the cannula, it would not retract.She saved it for me to look at, and it would not for me also.When i placed it into a container (clean urinal) to save for your potential exam, the needle retracted on its own.However i do still have it in case.I¿m attaching the outer packaging with the lot number.By the way, what do the small numbers in blue mean (just to the left of the bottom corner of the blue box on the packaging).We found another one with the number 10 on it that at first did not retract but then suddenly did.Not sure if anyone has reported an issue with this, but one of the adult infusion nurses reported she started an iv on a patient and when she pressed the button to retract the metal needle from the cannula, it would not retract.Lot analysis: device/batch history record review: no.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 (mdr).Findings: as this complaint was a mdr; dhr review was performed on the following lot number: 7146918 ¿ the lot was built on afa line 2 from may 28, 2017 through may 31, 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: a review of the qn/sap database is not required for a s1 - o1 level a investigation per (b)(4).Visual analysis: observations and testing: received one used iag 22ga unit with an open package from the lot number 7145918.The unit consisted of the needle/safety barrel assembly.Visual/microscopic examination: the needle was fully retracted into the safety barrel and the white button was depressed.The needle was reassembled to the out position, observed there was no mechanical/physical damage to the springs or needle hub or grip.There was no evidence of adhesive on the button, grip or hub.Functional test (needle retraction) was performed: the white button was depressed and the unit did retract.The retraction was successful, meeting no resistance.Test description method no results visual/microscopic, na, see observations and testing.Functional (needle retraction), n/a, see observations and testing.Investigation samples(s) meet manufacturing specifications: yes, the returned unit for provided evaluation met and performed to manufacturing specifications.Investigation conclusion: conclusions: the defect of needle retraction slow; as stated in the subject of the pir was not confirmed.The returned unit did not display any adverse characteristics that would contribute to the defect the customer experienced, per the pir.The defect described in the incident report could not be confirmed or replicated with the returned unit.Did the evaluation confirm the customer¿s experience with the bd product? no; the customer experienced was not confirmed based on the evaluation and testing that was performed on the returned unit.Were we able to reproduce the customer's experience with the bd product? no; reproduction of the customer¿s experience was not achieved with the testing performed on the returned unit.Was the device used for treatment or diagnosis? treatment.Root cause description: root cause: relationship of device to the reported incident: indeterminate.Comment: there was no definite physical or mechanical evidence that confirmed and supported manufacturing process related issues for the defect observed in this incident.

• Brand Name: 22 G X 1.00 IN. 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: 6940758
• MDR Text Key: 90236312
• Report Number: 1710034-2017-00242
• Device Sequence Number: 1
• Product Code: FOZ
• 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: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

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
• Device Operator: Nurse
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 381423
• Device Lot Number: 7146918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/11/2017
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2017
• 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