MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 50ML S/T LATEX FREE CONFIGURE; PISTON SYRINGE

Model Number	309654
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.Unknown, (b)(6) has been used as a placeholder based on the reported phone area code.Investigation summary: a device history record review was completed by our quality engineer team for provided material number 309654 and lot number 9275448.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Further action has not been determined necessary at this time.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 scale markings came off the syringe 50ml s/t latex free configure after washing and reusing it for about 2 days.The following information was provided by the initial reporter: "the problem we have is that the markings on the syringe come off so fast.We have to reuse the syringes because of what insurance will allow.My son gets 50ml flushes every 2 hours and we only wash the syringe about 1 time a day but the markings wear off in about 2 days".

• Brand Name: SYRINGE 50ML S/T LATEX FREE CONFIGURE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11655241
• Report Number: 1911916-2021-00300
• Device Sequence Number: 14330384
• Product Code: FMF
• UDI-Device Identifier: 30382903096542
• UDI-Public: 30382903096542
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2021

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: Lay User/Patient
• Device Expiration Date: 09/30/2024
• Device Model Number: 309654
• Device Catalogue Number: 309654
• Device Lot Number: 9275448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1