MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SAFETYGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305905
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: piston syringe.Medical device type: fmf.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980987 (syringe).Pma / 510(k)#: k951254 (needle).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the scale on the bd safetyglide¿ needle was misaligned.The following information was provided by the initial reporter: "scale crooked.".
Additional Manufacturer Narrative
H.6.Investigation: it was reported the scale marking is crooked.To aid in the investigation, one photo was provided for evaluation by our quality team.The photos shows a syringe with a safetyglide needle assembly connected to it.The syringe has the scale printing skewed.This defect could occur if there is a jam in the printing process inducing the symptom reported by the customer.A device history record review was completed for provided material number 305905, lot number 0342777.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the printing process was performed.All the settings were correct and the flow of product was good.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.H3 other text : see h.10.
Event or Problem Description
It was reported that the scale on the bd safetyglide¿ needle was misaligned.The following information was provided by the initial reporter: "scale crooked".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evaluation? yes.D10: returned to manufacturer on: 2021-12-02 h6: investigation summary it was reported the scale marking is crooked.To aid in the investigation, one sample and one photo were provided for evaluation by our quality team.The sample received is a safetyglide needle assembly with the plastic shield, but no packaging.The safety mechanism has not been activated.A visual inspection was performed and no defects or imperfections were observed on the needle assembly.The photos shows a syringe with a safetyglide needle assembly connected to it.The syringe has the scale printing skewed.One sample of a 3ml syringe was also received.It is the sample that is shown in the photo.This defect could occur if there is a jam in the printing process inducing the symptom reported by the customer.A device history record review was completed for provided material number 305905, lot number 0342777.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the printing process was performed.All the settings were correct and the flow of product was good.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 is confirmed.
Event or Problem Description
It was reported that the scale on the bd safetyglide¿ needle was misaligned.The following information was provided by the initial reporter: "scale crooked".

• Brand Name: BD SAFETYGLIDE¿ NEEDLE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12544329
• Report Number: 1911916-2021-01031
• Device Sequence Number: 4584715
• Product Code: FMI
• UDI-Device Identifier: 30382903059059
• UDI-Public: 30382903059059
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H.10.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2021

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: 11/30/2025
• Device Model Number: 305905
• Device Catalogue Number: 305905
• Device Lot Number: 0342777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 09/29/2021; 12/11/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/22/2021; 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2021
• 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