MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 25 G BD¿ NEEDLE 1 IN. SINGLE USE, STERILE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305125
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: it was reported the needles are blocked at the tip of the needle.To aid in the investigation, six photos were provided for evaluation by our quality team.The photos show a needle with a foreign matter at the needle point.This is identified in the photos with a red circle.No other information could be obtained from the photos.A device history record review was completed for provided material number 305125, lot number 0301770.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.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 physical sample analysis a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the 25 g bd¿ needle 1 in.Single use, sterile was clogged.The following information was provided by the initial reporter: the needle was inspected under optical microscopy and we found what appeared to be ¿blockage¿ near the tip of the needle.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evalution?: yes.D10: returned to manufacturer on: 25-oct-2022 h6: investigation summary it was reported the needles are blocked at the tip of the needle.To aid in the investigation, one sample with the plastic shield, but no packaging blister, and six photos were provided for evaluation by our quality team.A visual inspection was performed.First, with a 10x magnifier lens and then with a 30x microscope and no defects or imperfections were observed.The sample was then connected to a syringe with saline solution.The solution expelled with a normal flow.The photos show a needle with a foreign matter at the needle point.This is identified in the photos with a red circle.No other information could be obtained from the photos.A device history record review was completed for provided material number 305125, lot number 0301770.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed, and a probable root cause could not be offered.
Event or Problem Description
It was reported that the 25 g bd¿ needle 1 in.Single use, sterile was clogged.The following information was provided by the initial reporter: the needle was inspected under optical microscopy and we found what appeared to be ¿blockage¿ near the tip of the needle.

• Brand Name: 25 G BD¿ NEEDLE 1 IN. SINGLE USE, STERILE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15695704
• Report Number: 1911916-2022-00592
• Device Sequence Number: 7359622
• Product Code: FMI
• UDI-Device Identifier: 30382903051251
• UDI-Public: 30382903051251
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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: Other
• Device Expiration Date: 02/28/2026
• Device Model Number: 305125
• Device Catalogue Number: 305125
• Device Lot Number: 0301770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown