MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE ORAL 50ML CLEAR STERILE; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number	305863
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no samples were received.No photos were provided.After the barrel molding process, the barrel goes to the barrel printing process.It may have happened that the machine run low on ink and the barrels did not get the scale printed and not detected in the next processes.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: it may have happened during syringe assembly printing process.Rationale: capa not required at this time.
Event or Problem Description
It was reported that syringe oral 50ml clear sterile had no scale markings.This was discovered before use.The following information was provided by the initial reporter: material no: 305863 batch no: 9275383.It was reported that when rn was pulling her supplies, it was noticed that there no volume markings.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d.10.Device available for eval? yes.D.10.Returned to manufacturer on: 2020-07-06.H.3.Device returned to manufacturer: yes.H.3.Device eval by manufacturer: yes.H.6.Investigation summary: one sample was received on july 6, 2020.A visual inspection was performed.It came in an opened packaging blister.The syringe barrel has the scale marking missing.No other defects were observed.Based on the investigation and the sample analysis the symptom reported by the customer is confirmed.The history of this product was analyzed from 2018 to (b)(6) 2020.This is the 1st complaint during the period analyzed.We will continue monitoring the complaints of this product and symptom.Investigation conclusion: this is the 1st complaint for lot # 9275383 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: it may have happened during syringe assembly printing process.Rationale: capa not required at this time.
Event or Problem Description
It was reported that syringe oral 50ml clear sterile had no scale markings.This was discovered before use.The following information was provided by the initial reporter: material no: 305863.Batch no: 9275383.It was reported that when rn was pulling her supplies, it was noticed that there no volume markings.

• Brand Name: SYRINGE ORAL 50ML CLEAR STERILE
• Common Device Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10061402
• Report Number: 1911916-2020-00464
• Device Sequence Number: 3751919
• Product Code: KNT
• UDI-Device Identifier: 30382903058632
• UDI-Public: 30382903058632
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112434
• Number of Events Summarized: 1
• Summary Report (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): 07/07/2020

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 Expiration Date: 09/30/2024
• Device Model Number: 305863
• Device Catalogue Number: 305863
• Device Lot Number: 9275383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other