MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 8MM 90 BX 450 MO; PISTON SYRINGE

Model Number 328291

Device Problems Volume Accuracy Problem (1675); Defective Device (2588)

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

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Event Description

It was reported when using the bd syringe 0.3ml 8mm 90 bx 450 mo, the device experienced scale marking issues and damaged product.The following information was provided by the initial reporter.The customer stated: it was reported incorrect scale print, smeared scale print, thumb press fell off of the plunger rod when plunger cap was removed, bottom of plunger rod appeared to be melted.Verbatim: from phone call on 2021-09-20 13:03:44: called consumer to follow up on complaint.Consumer stated that she had issues with syringes over the years.Her current box has one issue where the thumb press on the plunger rod fell off when she removed the cap.The previous boxes had issues with the scale print being smeared, needle bent and air bubbles in the syringe.Consumer does not have the lot #s for the previous boxes, packaging and samples have been discarded.Js.Issues: lot #: 1039358: plunger rod damaged-thumb press fell off of the plunger rod when plunger cap was removed; bottom of plunger rod appeared to be melted.Catalog #: 328291.Date of event: unknown.Samples: discarded.Unknown lots: same product # (328291); incorrect scale print; smeared scale print ; air bubbles in syringes; needles bent; needles missing; catalog #: 328291; date of event: unknown; samples: discarded.Verbatim from email: good morning, i have been a type 1 diabetic for 47 years and have been using bd insulin syringes as long as i can remember.I never had any product concerns until this past year.Currently, i am using the u-100 ultra fine 3/10 ml syringes.The lot number on one box is iso 15223-1.I receive them through a mail order pharmacy as a 3 month supply.Only one syringe so far in this box had an issue (plunger base fell off), but i have noticed the below issues in random bags in different boxes with every reorder i have been receiving over the past year.Unfortunately i did not save the affected syringes.I didn't think of sending you the information until i was telling a family member what i had seen.The issues have not caused me any harm.I discard any syringes with a flaw.The issues i have seen over the year include: smeared dose numbers, the entire dosage "stamp" was not straight (all numbers were in line with each other but not straight down the barrel itself), end of plunger (round part) just fell off when i took off bottom protector cap, deformed (looked melted) plunger (bottom of it), syringe with no needle, bent needles from the base of syringe (this is most common issue), some syringes have small amount of air (plunger down slightly) and others have no air so i'm not sure what the expected way it should be.

• Brand Name: BD SYRINGE 0.3ML 8MM 90 BX 450 MO
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12648190
• MDR Text Key: 282110785
• Report Number: 1920898-2021-01085
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903282913
• UDI-Public: 00382903282913
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2021
• Device Model Number: 328291
• Device Catalogue Number: 328291
• Device Lot Number: 1039358
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1