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

Catalog Number 300928

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation summary: bd has been provided with 1 reference sample to investigation for this record.Visual inspection of the returned sample presented no defects.Bd was not able to verify the reported issue.The material used to manufacture discardit syringes has been selected and tested to resist normal conditions of use.The assembling machines have an on-line detection system that inspects 100 % the syringes, rejecting automatically the syringes with broken parts like the tip of the barrel.We must also consider the plastic materials get brittle with low temperatures.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 one reference sample.Visual inspection of the returned sample presented no defect.We could not confirm 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 qn nor ncmr's.Syringes were packed in machine (b)(4) (december 4th - 7th, 2017).Syringes were assembled in machine (b)(4), in lot #7331798 (november 27th - december 4th, 2017) and lot #7338934 (december 4th - 11th, 2017).Research has found no defect related to the reported issue.We have also reviewed the barrel lots #7338611, #7331812, #7325878, and #7318863, and no problems, defects or qn were found.We have also reviewed the plunger lots #7338617, #7331816, #7325882, and #7311696, and no problems, defects or qn were found.Root cause description: root cause analysis: the material used to manufacture discardit syringes has been selected and tested to resist normal conditions of use.The assembling machines have an on-line detection system that inspects 100 % the syringes, rejecting automatically the syringes with broken parts like the tip of the barrel.We must also take into account that plastic material is getting brittle with low temperatures.Confirmation: the returned sample did not present the reported issue.No issue found in the bhr review.We could not 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.Rationale: 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 the inner part of the bd discardit¿ ii syringe is falling into pieces.Found before use.No reports of serious injury or medical intervention noted.

• 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: 7565349
• MDR Text Key: 110466471
• Report Number: 3002682307-2018-00129
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 300928
• Device Lot Number: 1712159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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