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

Catalog Number 381834

Device Problem Device Packaging Compromised (2916)

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

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: three sample units were received for evaluation by our quality engineer team. Upon examination, all three units were observed to be partially open at both ends of the blister packaging. The packages were analyzed under uv light as the adhesive is uv fluorescent. The analysis revealed an adequate amount of top web adhesive. 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. Device/batch history record review: 6078565 ¿ the lot number was manufactured on afa line 7 from 6 mar 2016 through 31 mar 2016 and packaged on packaging line 9 from 26 mar 2016 to 18 jul 2016 (stopped and re-started). During the production of the lot 4 qn¿s were initiated, 2 of which were related to an open package defect due to a malformed bottom web pocket. These resulted in destroying or re-packaging affected product. A total of (b)(4) units were repackaged: (b)(4) units were repackaged on pkg line 8 on 23 sep 2016 and (b)(4) on pkg line 9 from 19 sep 2016 through 22 sep 2016. In process inspections (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, and disposition of the product, root cause and corrective action(s) were applied according to the quality control plan. 5348960 ¿ a total of (b)(4) units were manufactured on afa line 6 on 16 dec 2015 through 20 dec 2015 and packaged on packaging line 9 from 21 dec 2015 through 23 dec 2015. In process inspections (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications. 5107713 ¿ a total of (b)(4) units were manufactured on afa line 1 on 19 apr 2015 through 24 apr 2015 and packaged on packaging line 8 from 22 apr 2015 through 28 apr 2015. In process inspections (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications. Observations and testing: received a total of 3 unused units iag 20ga, one unit from each lot reported on the parent record (5348690, 6078565, 5107713). Visual/microscopic examination: all units received were partially open at both ends of the packages. The sample from lot 6078565 was visually inspected and confirmed that the bottom web pocket was correctly formed; the reported open seal issue reported with this complaint is not associated with the defect found with (b)(4). The analysis of top web adhesive: the product characteristics require a minimum of 1/8¿ seal transfer. This characteristic was met. In addition the paper top web of the returned unit was analyzed under uv light. The glue used to seal the top and bottom webs is uv fluorescent. The analysis revealed an adequate of top web adhesive. The key variables that affect seal strength are: seal transfer/width and top web glue. Both of these variables were looked at during the investigation. The returned units provided for evaluation for this incident met the manufacturing specification requirements. Was the device used for treatment or diagnosis? treatment investigation conclusion: the defect stated in the event description was confirmed with the returned unit. Even though the reported defect was confirmed, all the processes characteristics that directly influence the seal strength were observed to be within specification. No anomalies were found. The customer experience was confirmed based on the evaluation that was performed on the returned units. It was not necessary to achieve reproduction of the customer¿s experience, as the defect was confirmed. 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.

Manufacturer Narrative

Three potential lot numbers were provided for this incident. The information for each lot number is as follows: medical device lot #: 5348960. Medical device expiration date: 11/30/2018. Device manufacture date: 12/14/2015. Medical device lot #: 5107713. Medical device expiration date: 04/30/2018. Device manufacture date: 04/17/2015. Medical device lot #: 6078565. Medical device expiration date: 02/28/2019. Device manufacture date: 03/18/2016. 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 part of the package was found opened on a bd insyte¿ autoguard¿ shielded iv catheter prior to use. There was no report of injury or medical intervention.

• 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
• MDR Report Key: 7131172
• MDR Text Key: 282333191
• Report Number: 1710034-2017-00512
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381834
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/19/2017 Patient Sequence Number: 1