MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE

Catalog Number 300928

Device Problem Gas/Air Leak (2946)

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

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 a bd discardit¿ ii syringe contained air bubbles.No report of serious injury or medical intervention.

Manufacturer Narrative

Additional information: a sample was provided for evaluation.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: yes.Investigation summary: bd has been provided with the affected sample.A leakage through the plunger rod was observed in two of these provided samples.After that bd could determine a damage in the plunger rod by the evaluation of the plunger with magnification.Bd could confirm the reported issue.After the evaluation of the received sample, bd concludes that the cause of the problem was produced as a consequence of a damage in the plunger lip.This could be produced during the handling of the product through the manufacturing process or in the plunger assembly machine.

Event Description

It was reported that a bd discardit¿ ii syringe contained air bubbles.No report of serious injury or medical intervention.

Event Description

It was reported that a bd discardit¿ ii syringe contained air bubbles.No report of serious injury or medical intervention.

Manufacturer Narrative

We have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Syringes were packed in machine nº2026 (february 6th - 9th, 2018).Syringes were assembled in machine, nº4239, nº4238, nº4214, nº4206, and nº4201, in lot #8029656 (january 29th ¿ february 5th, 2018) and in lot #8036710 (february 5th ¿ 12th, 2018).Research has found no problems, defects or qn related to the reported issue.We have also reviewed the barrel lots #8037755, #8030574, #8022717, and no problems, defects or qn related to the reported issue were found.We have also reviewed the plunger lots #8037762, #8030578, #8022721, #8015642, #7354661 and no problems, defects or qn related to the reported issue were found.Based on the customer feedback of the issue, bd concludes that the cause of the problem could be produced as a consequence of a damage in the plunger lip.This could be produced during the handling of the product through the manufacturing process or in the plunger assembly machine.Not able to determine.Damage in the plunger lip produced during the handling of the product through the manufacturing process or in the plunger assembly machine.We can ensure that the probability of finding this kind of defect is very low and any recurrence is really unlikely in our products since review syringe dhr showed no indication of the alleged defect, considering our in-coming and in-process inspection and since this is the first time this lot is reported for this defect, no actions are required.

• Brand Name: BD DISCARDIT¿ II SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7749611
• MDR Text Key: 116389032
• Report Number: 3002682307-2018-00192
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 300928
• Device Lot Number: 1802149
• Date Manufacturer Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other