MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS 10ML PRE-FILLED FLUSH SYRINGE NACL 0.9%

Catalog Number 306572

Device Problems Delivered as Unsterile Product (1421); Defective Component (2292); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).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 the sterile packaging was breached on a bd posiflush¿ xs 10ml pre-filled flush syringe nacl 0.9% package due to damaged/defective packaging.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: a device history record review showed no rejected inspections or quality issues during the production of the reported batch number that could relate to the issue of package perforation.As no samples were provided for evaluation and no anomalies were found during production, bd was unable to confirm the reported issue.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.The maintenance plans for the perforation station are under review in our 2018 quality improvement plan.Root cause description: 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-conformance's associated with this failure mode for the lot number listed in connection with this complaint.Without a sample, an absolute root cause for this incident cannot be determined.

• Brand Name: BD POSIFLUSH¿ XS 10ML PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: 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: 6952691
• MDR Text Key: 90256652
• Report Number: 9616657-2017-00012
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 306572
• Device Lot Number: 7221664
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2017
• 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