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

Catalog Number 381467

Device Problem Physical Resistance (2578)

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

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that several bd insyte¿ autoguard¿ shielded iv catheter(s) experienced a sterile breach (¿package spontaneously opening¿).It was also reported that resistance occurred when using the safety mechanism and the needle doesn't retract fully.There was no report of injury or medical interventions.

Manufacturer Narrative

Results: bd's quality engineer inspected the returned unit and confirmed the package was received open/partially peeled.The analysis conducted revealed an adequate amount of top web adhesive which was within specifications.The returned device was tested and retraction was successful as there was no delayed reaction to the needle retracting.We were unable to determine a root cause for this incident based on the provided sample.The samples were visually and microscopically evaluated and the customer's indicated failure mode for leakage with the incident lot was observed.A device history record review showed no non-conformances associated with this issue during the production of this batch.Conclusion: the defect package seal integrity poor/questionable, as stated in the description of the complaint was confirmed with the returned unit.Even though the package was partially opened, all the processes characteristics that directly influence the seal strength were observed to be within specification.No anomalies were found.The defect of needle retraction failure as stated as the reported coded was not confirmed with the returned units.No physical mechanical evidence was found to trigger the failure and the unit successfully retracted upon activation of the white button.Package seal integrity: although the packages were observed to be partially opened, there was no physical evidence to confirm or to support manufacturing process related issues for the defect.Needle retraction failure: the returned units did not display any adverse characteristics that would contribute to the defect the customer experienced.The defect that was described could not be confirmed or replicated with the returned representative unit.The actual unit described in the incident report was not returned for evaluation.Refer to (b)(4).

• Brand Name: 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: 7089331
• MDR Text Key: 94814915
• Report Number: 1710034-2017-00432
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814672
• UDI-Public: 30382903814672
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 381467
• Device Lot Number: 6237840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2016
• 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