MAUDE Adverse Event Report: BECTON DICKINSON DISCARDITII 2ML SYRG; SYRINGE

Catalog Number 300849

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter addr 1: (b)(6).Investigation summary: no samples (including photos) were returned for the reported issue of ¿in one pack syringe marking of 1 ml is not shown properly.In some syringe marking it has become light and become black when we touch and slightly rub on marking¿ with lot number 1129916 regarding item # 300849, so retention samples were used for the investigation.The dhr of material number 300849 and lot number 1129916 was checked and no quality notification was recorded on this lot.No retention samples showed marking defect.The defect cannot be confirmed.The defect was simulated on the machine and on investigation it was found that this is mostly because of the toggle arm and bush was worn out and was overlooked during pm.As an action point for corrective and preventive action we have now been added the pm checklist to avoid overlooking and missing them on checking them out during preventive maintenance of the machine.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no capa is required at this time.Investigation conclusion: no samples and no photographs were received from the customer and were used for investigation of the reported defects.The investigating team has used the retention samples of material code 300849 and lot number 1129916 for investigating the reported defect.No retention sample showed marking defect.The defect cannot be confirmed.The defect was simulated on the machine and on investigation it was found that this is majorly because of the toggle arm and bush worn out and got overlooked during pm as an action point for corrective and preventive action we have now been added the pm checklist to avoid overlooking and missing them on checking them out during preventive maintenance of the machine.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

Event Description

It was reported that the discarditii 2ml syrg experienced scale marking issues.The following information was provided by the initial reporter: syringe marking is become light and hand become black when when we touch and slightly rub on marking.In one pack syringe marking of 1 ml is not shown properly.In some syringe marking is become light and hand become black when when we touch and slightly rub on marking.

• Brand Name: DISCARDITII 2ML SYRG
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12557166
• MDR Text Key: 274250400
• Report Number: 2243072-2021-02423
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300849
• Device Lot Number: 1129916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2021
• 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