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

Catalog Number	381467
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7207846, medical device expiration date: 07/31/2020, device manufacture date: 07/26/2017; medical device lot #: 6119986, medical device expiration date: 04/30/2019, device manufacture date: 04/28/2016; medical device lot #: 6215627, medical device expiration date: 07/31/2019, device manufacture date: 08/03/2016; medical device lot #: 6308948, medical device expiration date: 10/31/2019, device manufacture date: 11/08/2016; medical device lot #: 7047550, medical device expiration date: 01/31/2020, device manufacture date: 02/16/2017; medical device lot #: 7051627, medical device expiration date: 01/31/2020, device manufacture date: 02/20/2017; medical device lot #: 7137811, medical device expiration date: 04/30/2020, device manufacture date: 05/17/2017.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd insyte¿ autoguard¿ shielded iv catheter had a sterile breach due to packaging that was slightly opened.There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported that a bd insyte autoguard shielded iv catheter had a sterile breach due to packaging that was slightly opened.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.A review of the device history record revealed no irregularities during the manufacture of the reported lot.Some returned packages were partially opened, but this is the basis of the complaint.Received a total of 96 units.The product characteristics require a minimum of 1/8" seal with adhesive transfer from the top web paper to the bottom web film.This characteristic was met.The key variables that affect seal quality are seal transfer/width and top web adhesive presence.Both of these variables were included in the investigation.Supplier oliver-tolas (ot) uses a standard reinforced paper that is common to many other suppliers, but the adhesive type and application is specific to ot.There is sufficient evidence to demonstrate the ot material or adhesive application is the root cause.(b)(4) was initiated to address the issue of open seal complaints.Tasks associated with the capa plan have been completed.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: 7802156
• Report Number: 1710034-2018-00551
• Device Sequence Number: 1293435
• Product Code: FOZ
• UDI-Device Identifier: 30382903814672
• UDI-Public: 30382903814672
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

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 Catalogue Number: 381467
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 11/06/2018
• 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