MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE¿ MANUAL NEEDLE GUARD

Catalog Number 47436630

Device Problems Crack (1135); Loose or Intermittent Connection (1371)

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

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 bd ultrasafe¿ manual needle guard green needle cover was cracked and loose.It is unclear when the event took place.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

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.This device was designed with a low clipping force to accommodate easily all types of syringes during device assembly and so minimizing risk of flange or device breakage.The draw-back of this design is the relatively low retention force.Based on investigation conclusion the syringe most likely became detached as it was not clipped into the device or the product received an external impact after syringe insertion which caused the syringe to unclip from the device.The manual needle guards syringe flange holding clips were observed straight and properly aligned.The syringe flange and barrel were not cracked or broken.Based on the deformation seen on one of the holding clips the syringe was unclipped from the device.Therefore, the syringe most likely became detached as it received an external impact after syringe insertion.

Event Description

It was reported that bd ultrasafe manual needle guard green needle cover was cracked and loose.It is unclear when the event took place.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.

Event Description

It was reported that bd ultrasafe¿ manual needle guard green needle cover was cracked and loose.It is unclear when the event took place.No reports of serious injury or medical intervention noted.

• Brand Name: BD ULTRASAFE¿ MANUAL NEEDLE GUARD
• Type of Device: NEEDLE GUARD
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• MDR Report Key: 7634570
• MDR Text Key: 112334185
• Report Number: 3009081593-2018-00046
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K972878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 47436630
• Device Lot Number: 6349089
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other