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 Consequences Or Impact To Patient (2199)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k011369.Pma / 510(k)#: k122558.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use of the ultrasafe x100l png clear nvs stein the needle would not release into the skin when the button was pushed.Patient only received ½ dose but had no adverse effect from the reduced dose defective device not available for retrieval.The following information was provided by the initial reporter: spontaneous call received from patient who stated that needle would not release into skin when button was pushed.Patient only received ½ dose but had no adverse effect from the reduced dose defective device not available for retrieval.No additional information available.

Event Description

It was reported that during use of the ultrasafe x100l png clear nvs stein the needle would not release into the skin when the button was pushed.Patient only received ½ dose but had no adverse effect from the reduced dose defective device not available for retrieval.The following information was provided by the initial reporter: spontaneous call received from patient who stated that needle would not release into skin when button was pushed.Patient only received ½ dose but had no adverse effect from the reduced dose defective device not available for retrieval.No additional information available.

Manufacturer Narrative

H.6.Investigation: 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.

• 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: 8703968
• MDR Text Key: 148274074
• Report Number: 3009081593-2019-00153
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other,user facili
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 47439230
• Device Lot Number: 7033272
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other