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

Catalog Number 381823

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: dhr: the lot was built on afa line 5 from 05jun2018 through 11jun2018 and packaged on pkg.Line 9 from 13jun2018 through 15jun2018 for a quantity of (b)(4) ea.All required challenge samples, set-up and in process testing was performed in accordance with the quality plan.There were no indications of the reported defect throughout the build of this lot.Sap: there were no reject activity findings relevant to the defect associated with the lot number provided for this incident, as no qns were initiated for this lot.It was observed that there were traces of blue dried ink (non-foreign) on the top and/or bottom web of 31 of the 200 unit packages (blister packs) received for evaluation of this incident.These findings were physical evidence that confirmed that the reported defect was manufacturing process related.The fm was identified as dried ink (non-foreign).Investigation conclusion: photos: four photos were provided for evaluation of this incident.Photo ((b)(4)) shows four dispenser boxes with labeling from 22ga bd insyte autoguard, ref.381823, lot 8151930.Photo ((b)(4)) shows open dispensers from the top, revealing the product inside.This photo revealed ink spots on some of the packages (blister packs).Photo ((b)(4)) shows close-up view of the bottom web (clear film blister side) of three unit packages (blister packs) with excessive blue ink inside the package.Photo ((b)(4)) shows close-up view of three packages (blister packs) on the top web (label side) with blue ink spots.Samples: received four dispenser boxes from 22ga bd insyte autoguard, ref.381823, lot 8151930.The dispensers contained 50 units (packages) each all from lot 8151930 which had all components present and intact.All four dispensers contained some units (packages/blister packs) with excessive blue ink spots.Dispenser #1; contained 9 units (packages/blister packs) with blue ink spots on either or both the top and bottom web.Dispenser #2; contained 7 units (packages/blister packs) with blue ink spots on either or both the top and bottom web.Dispenser #3; contained 10 units (packages/blister packs) with blue ink spots on either or both the top and bottom web.Dispenser #4; contained 5 units (packages/blister packs) with blue ink spots on either or both the top and bottom web.Observations and/or testing: visual/microscopic: samples: it was observed that there were traces of blue dried ink (non-foreign) on the top and/or bottom web of 31 of the 200 unit packages (blister packs) received for evaluation of this incident.These findings were physical evidence that confirmed that the reported defect was manufacturing process related.The fm was identified as dried ink (non-foreign).Root cause description: the ink (non-foreign) substance present on the top and/or bottom web of the unit packages was introduced during the packaging process.The ink well was overfilled and spilled on the product below.

Event Description

It was reported that foreign matter occurred with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, "black rubbish like fm in the package.Correction: ink smear on packages.".

• 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 ; 8015652341
• MDR Report Key: 8586464
• MDR Text Key: 146408561
• Report Number: 1710034-2019-00504
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 381823
• Device Lot Number: 8151930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2018
• 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