MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X5/8 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305122
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	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Mat#: 305122 batch#: 3055928 it was reported by customer that when customer opened new needle, found it to have moisture and black material in needle hub.Problem information opened new needle, found it to have moisture and black material in needle hub.Occurrences: 1 each no adverse event reported.
Additional Manufacturer Narrative
(b)(4) initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f27 ¿ no patient involvement, device problem code: a180104 - device contamination with chemical or other material.
Event or Problem Description
Additional information received mat#: 305122, batch#: 3055928.It was reported by customer that when customer opened new needle, found it to have moisture and black material in needle hub.Verbatim: rcc received a complaint via email.Email(s) attached.Product information.Product code: 305122.Product description: needle hypo 25 x 5/8in.Lot/serial #: (b)(6).Expiry date: 2028-04-30.Problem information opened new needle, found it to have moisture and black material in needle hub.Occurrences: (b)(4) each.Reporter information reporter position/department: regulatory compliance sample information incident samples: 0.Representative samples: (b)(6) each.No adverse event reported 24oct2023.The incident date was 04-oct-2023.The complaint sample is not available for return as it was discarded upon discovery of the contaminants.There are however, (b)(4) needles remaining of the (b)(4) box that are currently quarantined, awaiting disposition.Kindly, please advise with regards to disposition and reimbursement.Avp would also be interested in any investigative findings, if/when available.
Additional Manufacturer Narrative
(b)(6) follow up for device evaluation.It was reported there was moisture and black material in the hub.To aid in the investigation, seventeen samples in sealed packaging blister and four photos were provided for evaluation by our quality team.A visual inspection was performed with 10x magnification, and no defects or imperfections were observed.Two photos show a packaging blister top web.The other two photos show a needle hub with a stain at the bottom.A device history record review was completed for provided material number 305122, lot 3055928.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 lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the actual sample analysis a probable root cause could not be offered.

• Brand Name: NEEDLE 25X5/8 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18054951
• Report Number: 1911916-2023-00816
• Device Sequence Number: 12505509
• Product Code: FMI
• UDI-Device Identifier: 30382903051220
• UDI-Public: (01)30382903051220
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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: 305122
• Device Lot Number: 3055928
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown