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

Catalog Number 309050

Device Problem Difficult to Advance (2920)

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

Event Date 10/26/2018

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 with the use of the bd discardit¿ ii syringe there was an issue with plunger movement difficult.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd has been provided with three affected samples.After the analysis of the samples, the high sliding force to glide the plunger rod was very apparent, so bd confirms the reported issue.Dhr review for lot#: 1602192: 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 nº2020 (february 17th - 18th, 2016).Syringes were assembled in machine, nº4210, nº4220, nº4237, nº4254, and nº4255, in lot#: 6043076 (february 15th ¿ 22nd, 2016).Research has found no problems, defects or qn related to the reported issue.We have also reviewed the barrel lots#: 6036035, #: 6043038, #: 6028412, and no problems, defects or qn related to the reported issue were found.We have also reviewed the plunger lots#: 6036039, #: 6043044 and no problems, defects or qn related to the reported issue were found.We have also reviewed the performed sliding test for this lot (february 26th, 2016), and all values were within specifications.After the evaluation of the received samples, bd concludes that the reported functionality defect is produced by improper injection in the barrel filling phase.It could occur cause if there is a particle inside the mold that produces stripes in the internal wall of the barrel.In extreme cases, that issue could produce functionality problems during the use of the syringe.Bd can ensure that the probability of finding this kind of defect is isolated and any recurrence is 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.

Event Description

It was reported with the use of the bd discardit¿ ii syringe there was an issue with plunger movement difficult.There was no report of injury or medical intervention.

• 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: 8061530
• MDR Text Key: 127872023
• Report Number: 3002682307-2018-00279
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 309050
• Device Lot Number: 1602192
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other