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

Catalog Number 381834

Device Problems Problem with Sterilization (1596); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7282722, medical device expiration date: 2020-09-30, device manufacture date: 2017-10-09.Medical device lot #: 7268945, medical device expiration date: 2020-08-31 , device manufacture date: 2017-09-25.Medical device lot #: 7222624, medical device expiration date: 2020-07-31, device manufacture date: 2017-08-10.(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 Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter had packaging seal failure which compromised the sterile barrier.No serious injury or medical intervention was reported.

Manufacturer Narrative

Dhr reviews; were conducted for this investigation which disclosed the following: lot 7282722; was manufactured on afa line 6 on (b)(6) 2017 through (b)(6) 2017 and packaged on pkg.Line 8 from (b)(6) 2017 through (b)(6) 2017 for the quantity of (b)(4) ea.There was one non-related temporary deviation (td-2017-60 ¿weekly maintenance; performed any day mon.Thru fri.On either day or night shift¿) were in affect during the build of this lot.All challenge, set up and in process samples were performed per quality control plan and all passed per specifications.Lot 7268945; was manufactured on afa line 6 starting on (b)(6) 2017 through (b)(6) 2017 and packaged on pkg.Line 8 from (b)(6) 2017 through (b)(6) 2018 for the quantity of (b)(4).There was one non-related temporary deviation (td-2017-60 ¿weekly maintenance; performed any day mon.Thru fri.On either day or night shift¿) were in affect during the build of this lot.All challenge, set up and in process samples were performed per quality control plan and all passed per specifications.Lot 7222624; was manufactured on afa line 6 starting on 16aug2017 through 18aug2017 and packaged on pkg.Line 8 from (b)(6) 2017 through (b)(6) 2017 for the quantity of (b)(4).There were two non-related temporary deviations (td 2017-77 ¿rational sampling per blitz #917-set-up sampling must be performed before starting production¿) and (td-2017-60 ¿weekly maintenance; performed any day mon.Thru fri.On either day or night shift¿) were in affect during the build of this lot.All challenge, set up and in process samples were performed per quality control plan and all passed per specifications.No samples or photos were provided for this incident.Relationship of device to the reported incident: indeterminate -no units or photos were provided for observation and/or testing of this incident therefore the alleged defect was not identified or confirmed and a root cause was not established.

Event Description

It was reported that bd insyte autoguard shielded iv catheter had packaging seal failure which compromised the sterile barrier.No serious injury or medical intervention was reported.

• 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: 7930670
• MDR Text Key: 122650591
• Report Number: 1710034-2018-00710
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 382903818341
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• 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 H.10
• Date Manufacturer Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other