MAUDE Adverse Event Report: BECTON DICKINSON DISCARDIT II 2 ML WITH 25G X 1; PISTON SYRINGE

Catalog Number 301866

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.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.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 6460 discardit ii 2 ml with 25g x 1 syringes had foreign particles, including black spots and hair, and leakage from damaged packaging units.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "syringes received with foreign particles, black spot, hair particle, marketing defects, no needle, double needle , blister leakage, damaged syringe".

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes.Returned to manufacturer on: 2021-07-16.Investigation summary the samples were received by bd for evaluation.A quality engineer was able to review the returned samples of (16) discardit 2ml with the reported issue of ¿syringes received with foreign particles, black spot, hair particle, marketing defects" with lot number 184543, regarding item # 301866.The dhr of material number 301866 and lot number 184543 was checked for any quality notification and no quality notification was recorded on this lot.Sixteen samples were received from the customer and were used for investigation of the reported defects.The investigating team also used the retention samples of material code 301866 and lot number 184543 for investigating the reported defect.The samples received for investigation have confirmed the defects reported by the customer.There are multiple defects reported in this complaint.The probable root cause and the action plan for each is as follows.The probable root causes are: blister damage complaint.- worn out bush and difference in chain positions at in and out.Foreign matter (black spot, hair, loose particle) ¿ dragging of bins on floor and overfilling of syringe hopper actions for blister damage complaints: all worn out bush to be replaced with new bush at bottom web loading station difference in both chain distance at in and out of m/c to be reduced to minimum difference sprocket to open change clits at laminate feeding station to be replaced because they are worn out static discharger to be fixed on flexi#1 machine after needle loader to eliminate static charge produced after needle loader sensor to be provided at bottom web station to detect the roll diameter and adjust motor speed accordingly on flexi#1 sensor to be provided at top web station to detect roll diameter and adjust motor speed accordingly on flexi#1 actions for foreign matter (black spot, hair, loose particle): trolley to be designed to carry bins from m&a machine to blister pack machine 2 bins (10000 syringes) will be filled in hopper at a time and maximum level indicated in hopper to be marked to update preventive maintenance checklist (m-f- 035) to include cleaning of syringe loader parts such as fingers, plate actions for needle missing & extra component in cavity: log sheet m-f-034 (flexi#1 primary pkg) to be updated to include vision camera challenge test in every b shift and record the results modify log sheet m-f-149 (flexi#2 primary packaging) to include vision camera challenge test in every b shift and record results in log sheet.Actions for barrel flange damage: h3 other text.

Event Description

It was reported that 6460 discardit ii 2 ml with 25g x 1 syringes had foreign particles, including black spots and hair, and leakage from damaged packaging units.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "syringes received with foreign particles, black spot, hair particle, marketing defects, no needle, double needle , blister leakage, damaged syringe".

• Brand Name: DISCARDIT II 2 ML WITH 25G X 1
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12215667
• MDR Text Key: 263462102
• Report Number: 2243072-2021-01959
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301866
• Device Lot Number: 0184543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1