MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE PASSIVE NEEDLE GUARD SYRINGE; SYRINGE, ANTISTICK

Catalog Number 47439230

Device Problem Failure to Deliver (2338)

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

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7117213; expiration date: 2022-04-30; manufacture date: 2017-04-27.Medical device lot #: 8128662; expiration date: 2023-04-30; manufacture date: 2018-05-08.Investigation summary: unconfirmed, no issue observed.Investigation conclusion: the customer issued a complaint for pre-activated 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 or correlate this symptom with a potential cause linked to bd process.During the years of investigation of complaints about pre-activated devices several root causes were discovered which were within the customer¿s sphere of influence.Best practices and guidelines were collected and summarized.Root cause description: complaint is unconfirmed.

Event Description

It was reported that no insulin flow occurred during use with a bd insulin syringe with bd ultra-fine¿ needle.The following information was provided by the initial reporter, "the pharmacist declared that a patient returned the product because during injection the syringe was blocked.(sample evaluation showed an activated safety device).

• Brand Name: BD ULTRASAFE PASSIVE NEEDLE GUARD SYRINGE
• Type of Device: SYRINGE, ANTISTICK
• 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 ; 8015652341
• MDR Report Key: 8841450
• MDR Text Key: 190431381
• Report Number: 3009081593-2019-00181
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2019

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: 04/30/2022
• Device Catalogue Number: 47439230
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/30/2019
• 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