MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE; SAFETY SYRINGE WITH NEEDLE

Catalog Number 47439230

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation results: summary: the customer issued a complaint for a plunger fell out device detected by end user.Neither sample nor photo was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.Based on investigation conclusion, bdm-ps was not able to confirm the symptom perceived by customer.Based on the investigation conclusion the defect occurred due to misuse of the combination product.The identified potential causes for plunger pulled out issues are all related to misuse/mishandling of the combination product by the end user.Bd ifu which was provided to our customer is detailed enough to avoid mishandling during removal of the combination product from blister or during preparation of the product for administration.Root cause:based on the investigation conclusion the defect occurred due to misuse of the combination product.The identified potential causes for plunger pulled out issues are all related to misuse/mishandling of the combination product by the end user.Bd ifu which was provided to our customer is detailed enough to avoid mishandling during removal of the combination product from blister or during preparation of the product for administration.

Event Description

It was reported that a bd ultrasafe passive¿ x-series needle guard syringe¿s plunger came off when the "patient opened the box the end of the syringe was loose and the medication leaked everywhere." there was no report of exposure, injury, or medical intervention.

• Brand Name: BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE
• Type of Device: SAFETY SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• Manufacturer (Section G): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7648835
• MDR Text Key: 112852956
• Report Number: 3009081593-2018-00044
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K122558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 47439230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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