MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305197
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	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material # 305197 batch # 4046343 it was reported by customer that issue with the 16 g bd precision guide needle.Could you please provide a further description of the issue? pharmacist came to me and said they found a floater in the syringe after using a bd precisionguide 16x1¿needle.It appeared to be part of the glue that links the metal needle to the plastic connector of the needle.2.Kindly provide the date of event? wednesday, (b)(6) 2024 3.Please share the material & lot number?needle, lot: 4046343, 2029-1-31 4.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No negative outcome other than a wasted bag of drug (don¿t remember name).Did not make it to the patient.
Event or Problem Description
No additional information received material # 305197 batch # 4046343 it was reported by customer that issue with the 16 g bd precision guide needle.Verbatim: rcc received a complaint via email.Email(s) attached.We have an issue with the 16 g bd precision guide needle.
Additional Manufacturer Narrative
Pr (b)(4) follow up.It was reported there was a floater in the syringe after using a bd needle.As the needle reported was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, one syringe sample and two photos were provided for evaluation by our quality team.The sample received is a 10ml syringe that is not produced by this site.A visual inspection was performed, and the syringe rubber stopper has a particle that is 1/16" in size.One photo provided shows a packaging blister top web.The other photo shows the sample received.The sample was sent to a laboratory for analysis.The closest match was 71.57% to silicone coated masking tape.The percent match is low and considered inconclusive.Since the foreign matter was adhered to the syringe rubber stopper, the presence of the existing silicone could have interfered with the testing results.A device history record review was completed for provided material number 305197, lot 4046343.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this needle lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: NEEDLE 16X1 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19229569
• Report Number: 1911916-2024-00302
• Device Sequence Number: 6883024
• Product Code: FMI
• UDI-Device Identifier: 30382903051978
• UDI-Public: (01)30382903051978
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: 305197
• Device Lot Number: 4046343
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown