MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 1ML CLEAR STERILE; GASTROINTESTINAL TUBE AND ACCESSORIES

Catalog Number	305851
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that before use of the syringe oral 1ml clear sterile the color of the plunger corresponding to batch 9064913 is different to all previous batches.There are 100 units that are affected.The following information was provided by the initial reporter: it was observed that the color of the plunger corresponding to batch 9064913 is different to all previous batches.It is lighter and opaque.
Additional Manufacturer Narrative
H.6.Investigation summary: one photo of two loose 1ml oral syringes were received and evaluated.It was observed one of the amber plunger rods had a much denser color than the other.This is a rejectable condition per the molding specification.Potential root cause for the variation in color defect is associated with the molding process.There is defined mixture ratios for the raw material but no color maps for comparison and no recipe in the quality system.Action taken: the mixture recipe will be added to the corresponding work instruction by 11/15/2019.Color maps will be assembled and added to the manufacturing floor by 1/17/2020.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see section h.10.
Event or Problem Description
It was reported that before use of the syringe oral 1ml clear sterile the color of the plunger corresponding to batch: 9064913 is different to all previous batches.There are 100 units that are affected.The following information was provided by the initial reporter: it was observed that the color of the plunger corresponding to batch: 9064913 is different to all previous batches.It is lighter and opaque.

• Brand Name: SYRINGE ORAL 1ML CLEAR STERILE
• Common Device Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9086830
• Report Number: 1213809-2019-00947
• Device Sequence Number: 1735292
• Product Code: KNT
• UDI-Device Identifier: 30382903058519
• UDI-Public: 30382903058519
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 305851
• Device Lot Number: 9064913
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/29/2019
• 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