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

Catalog Number 47450330

Device Problems Break (1069); Failure to Deliver (2338)

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

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7061118, medical device expiration date: 2022-02-28, device manufacture date: 2017-03-02.Medical device lot #: 8016559, medical device expiration date: 2022-12-31, device manufacture date: 2018-01-16." initial reporter phone #: unknown.Pma / 510(k)#: k011369, 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 the syringe flange is broken with a bd ultrasafe¿ passive needle guard syringe.The following information was provided by the initial reporter: the flange of a 150 mg xolair prefilled syringe broke by falling off.

Event Description

It was reported that the syringe flange is broken with a bd ultrasafe¿ passive needle guard syringe.The following information was provided by the initial reporter: the flange of a 150 mg xolair prefilled syringe broke by falling off.

Manufacturer Narrative

H.6.Investigation: neither photo nor sample part 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 a syringe can only become detached if syringe capture features or the flange of the syringe get damaged/broken or if the syringe receives an impact after syringe insertion which causes it to unclip from the device.Therefore, the syringe most likely became detached as it was not clipped into the device properly or it received an external impact after syringe insertion which caused it to unclip from the device.None of these causes are related to bd process.H3 other text : see h.10.

• Brand Name: BD ULTRASAFE PASSIVE NEEDLE GUARD SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• MDR Report Key: 9365375
• MDR Text Key: 216678569
• Report Number: 3009081593-2019-00265
• 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
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 47450330
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other