MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE; SALINE FLUSH

Catalog Number 306553

Device Problems Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that seals on the packaging of 10 ml bd posiflush¿ sf saline syringes were found breached prior to use.There was no report of injury or medical intervention.

Manufacturer Narrative

A device history record review found no documentation of any issues related to poor package seal during the production of this batch.Both picture samples and physical samples were received for evaluation.The investigation found foreign matter on the packaging as well as a breached seal.The foreign matter was confirmed to be a visual defect related to an interaction of the material during the sterilization process.The breached seal is likely to have been caused by excess temperature applied to certain areas of the seal.The preventive maintenance program related to the blister packaging machine has been reviewed, with specific focus on the sealing process.Additional preventive maintenance steps have been implemented to ensure the interval between sealing and gasket change out has been reduced from 48 hours to 24 hours.Problem statement: seal was breached.Each product was not sealed.Photo sample was received.The returned samples were inspected and confirmed to exhibit issues outlined by the customer.Complaint trending review of the lot for this issue reveals this is the first complaint.The non-conformance's were reviewed for this batch; there were no non-conformance's associated with this defect.Bd was able to duplicate or confirm the customer's indicated failure mode.Investigation comments: the foreign matter is a visual defect related to an interaction of the material with the sterilization process.The sample returned which exhibited a breached seal has been attributed to a maintenance interval.Product is not within specifications.Root cause: the foreign matter is caused by an interaction of the moist heat sterilization environment and a constituent of the paper top web.Based on a review of the physical appearance of the packs which exhibited a breached seal, the issue is likely to have been caused by excess temperature applied to this area of the seal.The preventative maintenance program related to the blister packaging machine has been reviewed, specifically focused on the sealing process.Additional preventive maintenance steps have been implemented to ensure the interval between sealing and gasket change out has been reduced from 48 hours to 24 hours.This was implemented post lot 7170621.The staining corrective actions are scheduled for implementation for q2 fy18, based on alternate material qualification.The preventative maintenance program related to the blister packaging machine has been reviewed, specifically focused on the sealing process.Additional preventive maintenance steps have been implemented to ensure the interval between sealing and gasket change out has been reduced from 48 hours to 24 hours.This was implemented post lot 7170621.The staining corrective actions are scheduled for implementation for q2 fy18, based on alternate material qualification.

• Brand Name: 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6911892
• MDR Text Key: 89487835
• Report Number: 9616657-2017-00011
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

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: 05/31/2020
• Device Catalogue Number: 306553
• Device Lot Number: 7170621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 09/08/2017
• Supplement Dates FDA Received: 11/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other