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

Catalog Number 382544

Device Problems Degraded (1153); Device Packaging Compromised (2916)

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

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 the seal on a bd insyte¿ autoguard¿ shielded iv catheter appears degraded, packets opening spontaneously therefore no longer sterile.No injury or medical intervention.

Manufacturer Narrative

H.6.Investigation summary: device/batch history record review findings: the lot number was built on afa line 9 from nov 21, 2016 thru nov 23, 2017 and packaged on packaging line 11 from nov 26, 2016 to nov 27, 2016.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that current risk is acceptable.Occurrence and severity rankings have not changed.Observations and testing: received 1 insyte autoguard bc 18ga unit from lot number 6321514.Exp.2019-10-31.Visual/microscopic examination: the package received revealed the top web (paper) was slightly lifted from the bottom web (clear) but the seal integrity was not compromised note: the product characteristics require a minimum of 1/8¿ seal width with adhesive transfer from the top web paper to the bottom web film.Conclusions: even though the package received revealed the top web (paper) was slightly lifted from the bottom web (clear) but the seal integrity was not compromised.Although the defect experienced by the customer was not confirmed with this particular incident, the failure is a known issue and was investigated under capa 48637.Capa 48637 was initiated to address the issue of open seal complaints.Tasks associated with the capa plan have been completed.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7613497
• MDR Text Key: 111917370
• Report Number: 1710034-2018-00301
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825449
• UDI-Public: 30382903825449
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• 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: 06/26/2018

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
• Device Operator: Other
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 382544
• Device Lot Number: 6321514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other