MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML S/T W/NDL 25X5/8 RB; PISTON SYRINGE

Catalog Number	309626
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 309626 batch#:unknown it was reported that the bd syringe 1ml s/t w/ndl 25x5/8 rb had foreign matter.It was reported by the customer that the base end of the needle at the hub there is a drip of excess silicone or plastic hanging onto the needle.Few millimeters of this foreign matter.Patient said that the insertion was painful as well.Verbatim: nurse calling on behalf of patient who picked up box of needles from pharmacy last week.The base end of the needle at the hub there is a drip of excess silicone or plastic hanging onto the needle.Few millimeters of this foreign matter.Patient said that the insertion was painful as well.Delay in treatment pharmacy did not replace needles because they didn't see the defect.Photos are available of this failure date of event- unknown happened last week he said the entire box of new needles all have this condition.Ref 309626 ndc- (b)(4).Additional information provided on 04/12/2024: hi, sorry for the delayed response.I don¿t know the answer to most of these questions, unfortunately.I didn¿t realize there would be additional steps, so i don¿t even have the patient¿s information handy at this point.The patient reported increased discomfort with use of these needles.I sent a new needle/syringe prescription to a different pharmacy, the patient purchased new needles/syringes, and i recommended that we review injection teaching in person so that we can rule out any other issues leading to increased discomfort.I don¿t know if i¿ll be able to obtain these from the patient, but you can send a return label to: (b)(6).If the patient ends up bringing these in, i can send them your way.Ruth.
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported there is a drip of excess silicone or plastic hanging onto the bottom of the needle hub.To aid in the investigation, two photos were provided for evaluation by our quality team.One photo shows a needle assembly with no packaging blister or plastic shield, and the area where the needle and needle hub join.The amount and shape of the epoxy is acceptable.The second photo shows a packaging blister top web.No defects or imperfections were observed.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.

• Brand Name: BD SYRINGE 1ML S/T W/NDL 25X5/8 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19139927
• Report Number: 1213809-2024-00238
• Device Sequence Number: 12870346
• Product Code: FMF
• UDI-Device Identifier: 30382903096269
• UDI-Public: (01)30382903096269
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: Health Professional
• Device Catalogue Number: 309626
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown