MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) ULTRASAFE X100L PNG CLEAR NVS STEIN; PISTON SYRINGE

Catalog Number 47439230

Device Problem Failure to Deliver (2338)

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

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/50(k)#: k011369, k122558.Unconfirmed, no issue observed.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.Rationale: complaint is unconfirmed.

Event Description

It was reported that 2 ultrasafe x100l png clear nvs stein experienced a broken syringe syringe/pen which was noted prior to use.The following information was provided by the initial reporter: consumer called to report that the needles in her syringes popped into the safety shields as soon as they were taken out of the box and that one of them even completely unattached itself from the syringe.

Manufacturer Narrative

The following information has been corrected: d.3.Reason code for no evaluation: other.D.3.If other specify: see h.10 h3 other text : see h.10.

Event Description

It was reported that 2 ultrasafe x100l png clear nvs stein experienced a broken syringe syringe/pen which was noted prior to use.The following information was provided by the initial reporter: consumer called to report that the needles in her syringes popped into the safety shields as soon as they were taken out of the box and that one of them even completely unattached itself from the syringe.

• Brand Name: ULTRASAFE X100L PNG CLEAR NVS STEIN
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• MDR Report Key: 9153237
• MDR Text Key: 195108833
• Report Number: 3009081593-2019-00225
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: K011369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• 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: 7117213
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other