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

Model Number 305863

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2020

Event Type  malfunction  

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 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.

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 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
• Type of Device: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10061402
• MDR Text Key: 196447313
• Report Number: 1911916-2020-00464
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 30382903058632
• UDI-Public: 30382903058632
• Combination Product (y/n): N
• PMA/PMN Number: K112434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other