MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 1/2IN 90 BX 450 MO; PISTON SYRINGE

Model Number 328280

Device Problem Defective Device (2588)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a syringe 0.3ml 1/2in 90 bx 450 mo was damaged before use.The following was reported by the initial reporter: "it was reported that the plunger cap is damaged and appears to be chewed.Also, the plunger rod is damaged and the thumb press is missing.Verbatim: consumer reported that the plunger cap is damaged, appears to be chewed up.Also reported plunger rod damaged, stated that the thumb press is missing.Lot #: 9259108.Catalog #: 328280.Date of event: unknownsamples: available - sending mail kit".

Event Description

It was reported that a syringe 0.3ml 1/2in 90 bx 450 mo was damaged before use.The following was reported by the initial reporter: "it was reported that the plunger cap is damaged and appears to be chewed.Also, the plunger rod is damaged and the thumb press is missing.Verbatim: consumer reported that the plunger cap is damaged, appears to be chewed up.Also reported plunger rod damaged, stated that the thumb press is missing.Lot #: 9259108 catalog #: 328280 date of event: unknown samples: available - sending mail kit".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/9/2021.H.6.Investigation: customer returned (1) 3/10cc, 12.7mm, 30g syringe in an open poly bag from lot # 9259108.Customer states that the plunger rod is damaged, appears to be chewed that the thumb press is missing.The returned syringe was examined and exhibited a bent plunger rod, a broken thumb press and a crushed plunger cap.A review of the device history record was completed for batch# 9259108.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There was one (1) notification [200847964] noted that did not pertain to the complaint.Maintenance dispatches (l2l) #79596 was created on 31oct2019 for syringe index jams.The jaw jam sensor broke that stops the ff&s equipment when more then one syringe enters the index dial.If a jam occurs at the indexer, damage to the cap/plunger end of the syringe can become damaged.H3 other text : see h.10.

• Brand Name: SYRINGE 0.3ML 1/2IN 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: 11248295
• MDR Text Key: 243845199
• Report Number: 1920898-2021-00124
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903282807
• UDI-Public: 00382903282807
• 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,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328280
• Device Catalogue Number: 328280
• Device Lot Number: 9259108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1