MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305125
Medical Device Problem Codes	Complete Blockage (1094); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Materials#: (b)(4) batch#: 2244893 it was reported by the customer that the cannula is restricted by a foreign material near needle opening within the needle hub and the voids which are not present in figure below on left (clogged needle) due to dried drug product residue.Verbatim: rcc received a complaint via email.Email(s) attached.Needle sku#: bd precision glide 25gx1¿ art.No.(b)(4) lot# 2244893 description: ¿ oot needle (figure below needle on left; shown by the arrow) demonstrates the cannula is restricted by a foreign material near needle opening within the needle hub.This is aligned with testing results of needle clogging/ blockage.¿ figure below on right circled region shows voids which are not present in figure below on left (clogged needle) due to dried drug product residue.The difference in contrast (i.E.Densities) between the foreign material causing blockage of needle (on left) and the dried drug product residue rule out that the foreign material is drug product related.Additional information: 1.Are you able to provide the dates of the events in the format of mm-dd-yyyy? if unknown, can state unknown.(b)(6) 2024.2.How was the patient outcome? are there any clinical signs, health consequences or impact? no human/animal impact as the needle was not used for human/ animal study.The needle was used for in-vitro study.3.Any physical sample available for investigation of affected product? if yes, are you able to provide the address of the facility for us to ship the return label? the needle is being analyzed and is unavailable at this time.We may be able to provide it at a later date once our evaluation is completed.
Additional Manufacturer Narrative
(b)(4) follow up: it was reported the cannula is restricted by a foreign material near the needle opening within the needle hub.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo appears to be an x-ray with magnification of what appears to be needle assemblies.Both have a red oval shape at the bottom of the needle.The figure on the left has an arrow pointing to where the oval shape is.No other information could be obtained from the photo.A device history record review was completed for provided material number 305125, lot 2244893.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 could not be confirmed.Without the actual physical sample analysis, a probable root cause could not be offered.
Event or Problem Description
Additional information received 1.Are you able to provide the dates of the events in the format of mm-dd-yyyy? if unknown, can state unknown.01-17-2024.2.How was the patient outcome? are there any clinical signs, health consequences or impact? no human/animal impact as the needle was not used for human/ animal study.The needle was used for in-vitro study.3.Any physical sample available for investigation of affected product? if yes, are you able to provide the address of the facility for us to ship the return label? the needle is being analyzed and is unavailable at this time.We may be able to provide it at a later date once our evaluation is completed.Materials#: 305125.Batch#: 2244893.It was reported by the customer that the cannula is restricted by a foreign material near needle opening within the needle hub and the voids which are not present in figure below on left (clogged needle) due to dried drug product residue.Verbatim: rcc received a complaint via email.Email(s) attached.Needle sku#: bd precision glide 25gx1¿ art.No.305125 lot# 2244893.Description: oot needle (figure below needle on left; shown by the arrow) demonstrates the cannula is restricted by a foreign material near needle opening within the needle hub.This is aligned with testing results of needle clogging/ blockage.Figure below on right circled region shows voids which are not present in figure below on left (clogged needle) due to dried drug product residue.The difference in contrast (i.E.Densities) between the foreign material causing blockage of needle (on left) and the dried drug product residue rule out that the foreign material is drug product related.

• Brand Name: NEEDLE 25X1 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: 18753244
• Report Number: 1911916-2024-00119
• Device Sequence Number: 11694702
• Product Code: FMI
• UDI-Device Identifier: 30382903051251
• UDI-Public: (01)30382903051251
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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: 305125
• Device Lot Number: 2244893
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown