MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS HEPARIN 100UL 5ML FILL IN 10ML SYRINGE; INTRAVASCULAR CATHETER

Catalog Number	306513
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that brown particles were found floating in the heparin 100ul 5ml fill in 10ml syringe prior to the injection.
Additional Manufacturer Narrative
H.6.Investigation summary: photo samples were provided to our quality engineer team for evaluation.Through visual inspection of the photo provided, foreign matter was observed in the syringe solution.Upon reviewing of the production history for the provided lot number 817121n , no deviations or non-conformances were identified during the manufacturing process.One-hundred and twenty retained samples of the reported lot number were visually inspected and no abnormalities were observed.Without a physical sample we could not conduct characterization analysis on the foreign matter.Based on the photo , we are not able to determined a root cause at this time.Based on photo provided, foreign matter was confirmed to be present in syringe solution.However, the type of foreign matter could not be determined from the photo; no physical sample was provided by the customer.100% of retained samples for the lot (120 units) were visually inspected.No foreign matter (i.E.Brown particles) was seen.Ftir analysis of the foreign matter was not able to be performed as no sample was provided.A review of the risk management documents was performed.There are no changes needed to the foreign matter risks, controls or ratings.The root cause analysis of the reported foreign matter is unknown.
Event or Problem Description
It was reported that brown particles were found floating in the heparin 100ul 5ml fill in 10ml syringe prior to the injection.

• Brand Name: HEPARIN 100UL 5ML FILL IN 10ML SYRINGE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 8359085
• Report Number: 2134319-2019-00101
• Device Sequence Number: 16544077
• Product Code: FOZ
• UDI-Device Identifier: 30382903065135
• UDI-Public: 30382903065135
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K011967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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 Expiration Date: 06/19/2020
• Device Catalogue Number: 306513
• Device Lot Number: 817121N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 03/04/2019
• 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