MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 20ML LS S/C 48; PISTON SYRINGE

Model Number	302831
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.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 medication used with the syringe 20ml ls s/c 48 stripped the scale marking ink off of the barrel.The following information was provided by the initial reporter: "customer needs to know if the ink used on syringe # (b)(4) is toxic to humans as one of their medications is stripping the ink off the syringe.".

• Brand Name: SYRINGE 20ML LS S/C 48
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11731244
• Report Number: 1911916-2021-00377
• Device Sequence Number: 3591257
• Product Code: FMF
• UDI-Device Identifier: 30382903028314
• UDI-Public: 30382903028314
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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 Model Number: 302831
• Device Catalogue Number: 302831
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1