MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ SLIP TIP SYRINGE; PISTON SYRINGE

Catalog Number	302833
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
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 a nurse found three defects in a bd¿ slip tip syringe.¿black foreign matter in syringe barrel and brown foreign matter in barrel tip; printing scale was not well printed; flange damaged¿.The device was not used and there was no report of injury or medical interventions.
Additional Manufacturer Narrative
Investigation summary: samples were received for evaluation by one of our quality engineers.The samples revealed skewed print, embedded foreign matter and damage to the syringe therefore the failure modes are verified.A quality alert has been issued to all applicable employees.One retained sample was also returned and used for testing.Dhr review: (b)(4) was produced on 2/7/2017 with zero defects found, nothing reported of any machine down time.Investigation conclusion: skewed print- can be caused by a misalignment of the load fingers or chains that press the syringe into the printing pad.Emfm- embedded fm can occur at the startup of the injection molding process.Solidified resin within the mold and molding press may become discolored or degraded when reheated.When starting the molding process, the press is put into "startup" where the press runs until any potential fm is flushed through the system.The press remains in startup until no fm is detected in inspections.Damage-possible jam from the misalignment of the load fingers or chains that press the syringe into the printing pad.
Event or Problem Description
It was reported that a nurse found three defects in a bd¿ slip tip syringe.¿black foreign matter in syringe barrel and brown foreign matter in barrel tip; printing scale was not well printed; flange damaged¿.The device was not used and there was no report of injury or medical interventions.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
Event or Problem Description
It was reported that a nurse found three defects in a bd¿ slip tip syringe.¿black foreign matter in syringe barrel and brown foreign matter in barrel tip; printing scale was not well printed; flange damaged¿.The device was not used and there was no report of injury or medical interventions.

• Brand Name: BD¿ SLIP TIP SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7500576
• Report Number: 1911916-2018-00199
• Device Sequence Number: 16173931
• Product Code: FMF
• UDI-Device Identifier: 30382903028338
• UDI-Public: 30382903028338
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2018

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: Nurse
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 302833
• Device Lot Number: 6354831
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 04/20/2018; 04/20/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 07/13/2018; 09/12/2018
• 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