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

Catalog Number 306553

Device Problem Contamination (1120)

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

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Results: investigation summary: samples were received for evaluation by our quality engineer team.Upon examination, the provided samples confirmed the reported defect.A single root cause could not be determined, but the cause may be associated with a perforation station issue, specifically a jam or misalignment.The maintenance plans for the perforation station will be reviewed for the 2018 quality improvement plan.Investigation conclusion: a device history was performed on lot 7244896.There were no non-conformances associated with this defect.Root cause: a single root cause is not fully assignable in this case but it may be associated with a perforation station issue, specifically a jam or misalignment.There were no non-conformances associated with this failure mode for the lot number listed in connection with this complaint.Other actions taken: the maintenance plans of the perforation station are under review in the 2018 quality improvement plan.

Event Description

It was reported that while opening several sterile 10 ml bd posiflush¿ sf saline syringes, the paper ripped contaminating 7 of the syringes.There was no report of injury or medical intervention.

• 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: 7136237
• MDR Text Key: 95669352
• Report Number: 9616657-2017-00018
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• 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
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 306553
• Device Lot Number: 7244896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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