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

Catalog Number 309110

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation summary: bd has been provided with 6 affected samples to investigate for this record.After the analysis of the samples, the high sliding force to glide the plunger rod was very apparent.As a result, bd was able to verify the reported issue of plunger/tip leakage.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.Based on our strict inspection plan, the reoccurrence of this issue is very low.Based on an evaluation of severity and occurrence it was determinate that no corrective action is required at this time.Investigation conclusion.Sample evaluation.We have been provided with 6 affected samples.After the analysis of the samples, the high sliding force to glide the plunger rod was very apparent, so we could confirmed the reported issue.Bhr review.We have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qa nor ncmr's.Syringes were packed in machine (b)(4) (february 21st - 22nd, 2017).Syringes were assembled in machine, (b)(4), in lot #7048467 (february 20th - 27th, 2017).Research has found no problems, defects or qn related to the reported issue.We have also reviewed the barrel lots #7048395, and #7041289 and no problems, defects or qn related to the reported issue were found.We have also reviewed the plunger lots #7048399, and #7041294 and no problems, defects or qn related to the reported issue were found.We have also reviewed the performed sliding test for this lot (march 2nd, 2017), and all values were within specifications.Root cause description.Root cause analysis.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.Based on our strict inspection plan, the recurrence of this issue is very low.Confirmation.The returned samples presented high sliding force.We could confirm the reported issue.Capa determination.No - based on an evaluation of severity and occurrence it was determinate that no corrective action is required at this time.

Event Description

It was reported that before use a bd discardit¿ ii syringe malfunctioned as"when preparing medication the plunger was hard to move and manipulate.The hcws thought drugs were changing the state of syringes however it seems that the whole batch 1702247 is concerned by this problem, the syringes are hard, almost "crystalized."there was no report of exposure, injury or medical intervention needed.

• Brand Name: BD DISCARDIT¿ II SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7574749
• MDR Text Key: 110591364
• Report Number: 3002682307-2018-00141
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 309110
• Device Lot Number: 1702247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other