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U.S. Department of Health and Human Services

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

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
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.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7930670
MDR Text Key122650591
Report Number1710034-2018-00710
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818341
UDI-Public382903818341
Combination Product (y/n)N
PMA/PMN Number
K952861
Number of Events Reported1
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 Received10/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381834
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/03/2018 Patient Sequence Number: 1
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