MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 1.0ML 31GA 8MM TW 10BAG 500 TWN; PISTON SYRINGE

Catalog Number 328820

Device Problem Volume Accuracy Problem (1675)

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that an unspecified number of syringe 1.0ml 31ga 8mm tw 10bag 500 twn had scale marking issues during use.The following was reported by the initial reporter: "frequent blunt needles, bubbles in plastic syringe barrel, and declining quality of barrel markings.(b)(6) contacted bd on behalf of his partner, (b)(6) , who uses 2-3 bd insulin syringes per day.(b)(6) uses the bd 328820 (1.0ml) and 328821 (0.5ml) insulin syringes.On average, she is experiencing 3-4 syringes per week with blunt needles, causing pain and bruising.He also reported a decline in the overall quality of bd insulin syringes 328820 and 328821.".

Event Description

It was reported that an unspecified number of syringe 1.0ml 31ga 8mm tw 10bag 500 twn had scale marking issues during use.The following was reported by the initial reporter: "frequent blunt needles, bubbles in plastic syringe barrel, and declining quality of barrel markings.

Manufacturer Narrative

The following field was updated due to corrected information: b.5.Describe event or problem: it was reported that an unspecified number of syringe 1.0ml 31ga 8mm tw 10bag 500 twn had scale marking issues during use.The following was reported by the initial reporter: "frequent blunt needles, bubbles in plastic syringe barrel, and declining quality of barrel markings.H.6.Investigation: no samples were returned therefore the investigation was performed based on the photos provided.Two photos of a 0.5ml syringe were provided.The customer reported frequent blunt needles, bubbles in plastic syringe barrel, and declining quality of barrel markings.The provided photos were examined, and it was observed that only a 0.5ml syringe was visible in the photos - the reported issues for 0.5ml syringes was captured in a different complaint.No photos of a 1ml syringe were provided, therefore, the alleged issue could not be confirmed.Due to the batch being unknown, no dhr review can be completed.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h.10.

• Brand Name: SYRINGE 1.0ML 31GA 8MM TW 10BAG 500 TWN
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11418539
• MDR Text Key: 252315889
• Report Number: 2243072-2021-00706
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328820
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1