MAUDE Adverse Event Report: BD LUER SLIP¿ SYRINGE TIP, 30 ML; PISTON SYRINGE

Model Number	302833
Medical Device Problem Code	Fungus in Device Environment (2316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that mold was discovered in 10 bd luer slip¿ syringe tip, 30 ml.The following information was provided by the initial reporter, translated from (b)(6) to english: it has received a complaint about 30ml syringe no.302833 from (b)(6) research institute, and 10 problematic syringes have been collected the customer complained of suspected mold in this batch of syringes.
Additional Manufacturer Narrative
Investigation summary: it was reported the customer complained of suspected mold in this batch of syringes.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows two syringes with dirty packaging.The syringes look good and no other defects or imperfections were observed.This defect could occur if the samples tested for packaging integrity became mixed with other product and were shipped to the customer.A device history record review was completed for provided material number 302833, lot number 8360688.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.The packaging integrity test process was verified.The product flow was correct and the samples being tested for packaging integrity were properly identified and segregated.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.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.

• Brand Name: BD LUER SLIP¿ SYRINGE TIP, 30 ML
• Common Device Name: PISTON SYRINGE
• MDR Report Key: 12755339
• Report Number: 1911916-2021-01143
• Device Sequence Number: 13816609
• Product Code: FMF
• UDI-Device Identifier: 30382903028338
• UDI-Public: 30382903028338
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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: 12/31/2023
• Device Model Number: 302833
• Device Catalogue Number: 302833
• Device Lot Number: 8360688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2018
• 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