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

Catalog Number	381033
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter had a sterility breach with the packaging.No serious injury or medical intervention was reported.Verbatim: "the integrity of sterile packaging of catheters is not conform.The packages are all open on the top.".
Additional Manufacturer Narrative
H.6.Investigation: review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.No qn were initiated on the build of this lot that could impact the outcome of the quality of the product relevant to the reported defect.Received one unused, iag bc 20ga x 1.0 inch unit consisting of a needle/grip subassembly with needle retracted and a needle cover.Packaging material included only the blister tray.There was no top web paper and therefore no evidence of lot number with the returned sample.Two photos were submitted for review: both photos displayed two different views of four partially opened packages; two 16ga, one 22ga and one 24ga.There is no 20ga unit in the photos.Visual/microscopic evaluation: the product characteristics require a minimum of 1/8¿ seal width with adhesive transfer from the top web paper to the bottom web film.This characteristic was met with the returned blister pack.The key variables that affect the packaging seal are seal transfer/width and top web adhesive presence.Top web adhesive presence could not be evaluated with the returned sample photos: based on the evaluation of the submitted photos, the photos displayed the top of the blister pack with partially peeled back top web.A 20ga package was not observed in the submitted photos.The defect of package seal integrity poor/questionable was not identified or confirmed with the returned unit or the provided photos.The paper top (label) was not returned with the bottom portion of the unit package.There was no 20ga package in the photos.Without a complete sample for evaluation and testing there was no physical/mechanical evidence to confirm or support manufacturing process related issues that would contribute to the reported defect.
Event or Problem Description
It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter had a sterility breach with the packaging.No serious injury or medical intervention was reported.Verbatim: "the integrity of sterile packaging of catheters is not conform.The packages are all open on the top.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8425629
• Report Number: 1710034-2019-00292
• Device Sequence Number: 1062256
• Product Code: FOZ
• UDI-Device Identifier: 00382903810338
• UDI-Public: 382903810338
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110443
• 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
• Report Date (Section B): 05/08/2019

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 Expiration Date: 06/30/2020
• Device Catalogue Number: 381033
• Device Lot Number: 7198573
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 05/08/2019
• 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