MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE INTEGRA 18X1-1/2 BLUNT FILL; PISTON SYRINGE

Catalog Number	305275
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: two (2) photos were provided by the customer for investigation.One (1) photo shows a filled syringe being held by a person.There is a reddish piece of foreign matter in the syringe.The second (2nd) photo also shows a filled syringe being held by a person.There is a brown piece of foreign matter in the syringe.A device history record (dhr) review was not able to be performed on the batch associated with this investigation as the batch number was not known.Investigation conclusion: confirmed: bd was able to duplicate or confirm the customer's indicated failure mode with the photos provided.Root cause description: without a physical sample to analyze the foreign matter (fm) that appears to be in the syringe cannot be identified; therefore, potential root causes cannot be determined, no corrective or preventative actions are proposed in the scope of this complaint.Rationale: 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.
Event or Problem Description
It was reported that rubber-like foreign matter was noticed floating in the needle integra 18x1-1/2 blunt fill during use after drawing up medication.The following information was provided by the initial reporter: "after drawing up medication using the bd blunt fill needle (without filter) the nurse noticed "floater in the medication syringe".She described it as resembling a small amount of rubber.".

• Brand Name: NEEDLE INTEGRA 18X1-1/2 BLUNT FILL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9203272
• Report Number: 1911916-2019-01099
• Device Sequence Number: 2258065
• Product Code: MEG
• UDI-Device Identifier: 30382903052753
• UDI-Public: 30382903052753
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305275
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/17/2019
• 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