MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 28GA 1/2IN BLS 500 SUS CA; PISTON SYRINGE

Model Number	329420
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that a syringe 1.0ml 28ga 1/2in bls 500 sus ca was found to be damaged during use.The following was reported by the initial reporter: it was reported that plunger rod is difficult to move and veins are blowing up.This causes pain to the patient.Verbatim: from phone call on 2021-04-06 16:57:37: consumer stated, plunger is hard to push on when taking injections.Stated, it gets stuck, causing her to push harder and as result, she experiences pain in her veins.Samples: yes, cl.Thanks for getting back to me.Many of your syringes have done that to me, where the plunger gets stuck (i think they're made too small so they stick).I've blown many veins due to this problem and yes, i also realize that iv drug use is also a high risk problem but i do know that if it weren't for your syringes, many of my veins would not have blown (up with air i think?).The product number is 329420.Lot #0262090.Information from email copied and pasted below: email received 2021-04-01 09:20:10.Sent wednesday, march 31, 2021 10:33 pm: "this is now the 2nd time i've complained.You guys sell to exchange works programs.I got my needles/syringes from them but it says becton dickinson on the box.I just want to complain because many times i've used them, they get stuck and very hard to press!!! because of that, i've ruined veins!! if they had of worked properly, my veins would be fine, not blown up!! but because many of them are hard to press and get stuck, then when i finally get it to "press", the whole ¿profanity¿ vein blows up (with air, i'm presuming!).You guys and your lack of quality control are causing many drug users veins to blow up!! i guess all you care about is money, so you sell them to the exchange programs, who are there to stop aids (and other diseases) to stop spreading.But, i assure you, that there are probably many other people like me who get "stuck" needles that when finally pressed (or should i say, when they finally work properly!), the whole friggin vein blows up.You think aids and other diseases are dangerous? well, so are your needles!!"".
Additional Manufacturer Narrative
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.A review of the device history record was completed for batch# 0262090.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
Event or Problem Description
It was reported that a syringe 1.0ml 28ga 1/2in bls 500 sus ca was found to be damaged during use.The following was reported by the initial reporter: "it was reported that plunger rod is difficult to move and veins are blowing up.This causes pain to the patient.Verbatim: from phone call on (b)(6) 2021 16:57:37: consumer stated, plunger is hard to push on when taking injections.Stated, it gets "stuck", causing her to push harder and as result, she experiences pain in her "veins".

• Brand Name: SYRINGE 1.0ML 28GA 1/2IN BLS 500 SUS CA
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11737018
• Report Number: 1920898-2021-00479
• Device Sequence Number: 17026106
• Product Code: FMF
• UDI-Device Identifier: 30382903294207
• UDI-Public: 30382903294207
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2025
• Device Model Number: 329420
• Device Catalogue Number: 329420
• Device Lot Number: 0262090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1